Hair

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To read the full article as it appears on The Huffington Post, click here. (1/20/17)

While 2016 may not go down as a lot of people’s favorite year, one development most people will agree to put a positive checkmark beside is the near-unanimous passing of the 21st Century Cures Act in the United States.

In the last breaths of its tenure, the Obama Administration was able to bring both sides of Congress, the patient community and industry lobbyists together in a consensus on what was needed to drive better, faster medical innovation in the years to come. Faster cures to future patients.

There are a lot of reasons to be pleased with the many provisions of the 21st Century Cures Act but as the CEO of a cell therapy company, RepliCel Life Sciences Inc., I’ll focus this brief post on the area in which I’ve dedicated most of my professional life.

Out of the spotlight of the more prominent provisions of the Act, is a section pertaining to what I predict will be a growing but eventually radical boost to the development of regenerative medicines such as “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products”.

Regenerative medicine is the idea that we can use cells or tissue from a patient or donor and do something more therapeutically significant for patients suffering from disease or conditions than we can do with drugs or other therapies. This next pillar of medicine dares to cure not just slow disease progression or reduce symptoms.

The 21st Century Cures Act promises not only foster the development of such therapeutic products but presents, I believe, exciting reasons to re-look at investing in cell therapy and other regenerative medicine companies. Here are four such reasons:

1. The Act clearly establishes this emerging sector of cell therapies and other regenerative medicines as an official part of the bio-pharmaceutical industry and the future of healthcare in America.

2. The Act provides for any product designated as a “regenerative advanced therapy” to be the beneficiary of ‘priority review’ by the FDA.

3. The Act mandates the FDA to define a pathway for ‘accelerated approval’ for products designated as ‘regenerative advanced therapies’.

Why does this radically change the investment thesis for cell therapy and regenerative medicine companies? It is almost impossible to imagine how ‘accelerated approval’ does not translate somehow into provisions that mimic conditional approval such as those implemented in Japan a couple years ago. While there will almost certainly be stringent post-marketing and/or patient registry obligations, this translates inevitably into a shorter clinical development pathway resulting in regenerative medicine products getting faster-to-market and the companies quicker-to-revenue. This shortens the return-on-investment window for those companies developing products likely to be eligible for the ‘regenerative advanced therapy’ designation.

4. The Act drives a further wedge between the ‘stem cell clinics’ providing ill-defined treatments with inadequate evidence that they work and the companies investing in regulated clinical trials and developing well-defined products. To the extent that patients and/or investors are confused by the distinction between such clinics and companies developing regulated products, the Act provides yet another piece of clarity and direction that Congress and the FDA will continue to step up efforts to ensure cell therapies are regulated and both patients and investments are protected from unregulated competition.

As larger-cap cell therapy companies such as Juno Therapeutics and Kite Pharma race for FDA market approval in 2017 based on relatively small phase 2 data, it is a prime opportunity for smart investors to look at the wave of cell therapy companies in the micro or nano-cap categories. I’m excited about what we’re doing at RepliCel Life Sciences with cell therapies for chronic tendon injury, pattern baldness and anti-aging of the skin and the series of clinical data announcements we have in early 2017 but there are a number of similarly exciting regenerative medicine companies worth attention (see, for example, the website of the Alliance for Regenerative Medicine, as a great resource for finding such companies).

Here’s to an exciting year for cell therapy companies, investors, products and – most importantly – the patients who will benefit from our daring to develop regenerative medicine cures.

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View featured company Article on Advisor Access click here

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View Article by Nick Waddell on Cantech Letter click here (1/11/2017)

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VANCOUVER, BC – September 26 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCD) (TSXV: RP) (Frankfurt: P6P2), (“RepliCel” or the “Company”), a clinical-stage regenerative medicine company focused on the development of autologous cell therapies, is pleased to provide an update on the licensing and co-development of its RCH-01 product with Shiseido Company.

As announced in July, RepliCel’s RCH-01 product, for the treatment of androgenetic alopecia, is now under clinical investigation at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama.

The product being tested in the clinical study, RCH-01, is an autologous cell therapy developed by RepliCel. Shiseido has an exclusive marketing license to the product for certain Asian countries under a License and Co-development Agreement signed by the parties in 2013.

The study is being financed by Shiseido Company and each product being injected will be manufactured by Shiseido at their SPEC (Cell-Processing and Expansion Center) facility in Kobe, Japan. RepliCel helped Shiseido design, validate, and prepare the SPEC facility for certification by Japan’s PMDA (Pharmaceuticals and Medical Device Agency). Shiseido’s SPEC team was also trained by RepliCel and Innovacell in the GMP (Good Manufacturing Practice) compliant production protocols for RCH-01.

While Shiseido’s manufacturing facility is certified by the Japanese PMDA, the clinical study is hospital-initiated and governed which means that Shiseido’s role in the trial is restricted to funding and manufacturing. Any eventual commercialization of the product in Japan as a result of this study would be done as a treatment provided in partnership with hospitals under the authority of the Ministry of Health, Labor and Welfare and its Act on the Safety of Regenerative Medicine.

“The pathway under which Shiseido has decided to conduct clinical investigation of RCH-01 in Japan means the product may be the subject of early commercialization in Japan,” stated RepliCel’s President and Chief Executive Officer, R. Lee Buckler “While we are unclear how the clinical strategy Shiseido is pursuing may impact the product’s commercialization in their markets, we remain supportive of Shiseido’s decisions,” continued Buckler.

“Since the license and co-development agreement was executed with Shiseido in 2013, RCH-01 has been carefully co-developed by the parties through a Joint Steering Committee established and governed by the agreement,” stated RepliCel’s Board Chairman and former CEO, David Hall. “The parties have been consistently cooperative and transparent as we work to collaboratively address the challenges and optimal product development strategy for RCH-01,” continued Hall.

“Because of financial constraints, RepliCel has not been able to proceed with its previously announced plans to initiate a phase 2 clinical trial of RCH-01,” stated RepliCel’s Buckler. “This has caused Shiseido to allege breach of our co-development obligations which we deny and vigorously oppose. While there is a clear obligation on our part to transfer data from such a trial when it is available, there is no express or implied obligations in the agreement as to when such a trial would have to be initiated or completed,” continued Buckler.

RepliCel owns unfettered market and development rights to RCH-01 outside of Shiseido’s territory in Asia. In the Agreement there are milestone payments and sales royalties flowing from eventual commercialization of the product in Shiseido’s territory. “In a worst case scenario wherein Shiseido is able to show breach of contract by RepliCel, we may lose some or all rights to milestone and royalty payments from Shiseido but still be in a position to capitalize on the product’s enormous potential everywhere else in the world. In the meantime, we remain steadfast to our position that the mutual obligations in the agreement remain intact,” Buckler concluded.

In the Agreement, Shiseido committed to sharing the clinical data from this study with RepliCel thus further strengthening the collective data package being created on RCH-01. While such data may be sufficient for Shiseido to bring RCH-01 to market in Japan, it will also be valuable to RepliCel to inform further product development and clinical testing decisions, for use in submissions to other regulatory agencies, and/or to support license negotiations for this product to parties for market rights outside of Shiseido’s exclusive territory.

Since the signing of the development Agreement, RepliCel has been working closely with Shiseido on the technology transfer, optimizing several features of the product’s manufacturing, and continuing to add to the body of science as it relates to the product and its intended function.

“We are excited that RCH-01 has the potential to be launched in the Japanese market by Shiseido sooner than anywhere else in the world,” stated RepliCel CEO, R. Lee Buckler, “and in the interim we continue to actively explore our global development and commercialization options for the product.”

About RCH-01

RCH-01 is an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia. To manufacture RCH-01, dermal sheath cup cells are isolated from a small punch biopsy taken from the back of a subject’s scalp. These cells are replicated in a GMP compliant cell production facility and the cells are then injected into balding areas on the same subject’s scalp. In clinical trials, after injections are performed, subjects return to the clinic at regular intervals for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well as for safety and data collection.

Since signing the regional licensing and co-development agreement, ReplCel and Shiseido have optimized the product and its manufacturing including building, validating, and obtaining PMDA certification of Shiseido’s facility purpose-built for this product, successfully completed the transfer of the manufacturing protocols and the product manufacturing validations, selected the clinical sites, trained all related personnel, and obtained regulatory clearance for the clinical study.

Market: $3.5 billion was spent on hair loss treatments in 2015 according to the Washington Post, with $2.5 billion of this spent on surgical procedures according to the International Society of Hair Restoration Surgery. We believe RCH-01 has the potential to capture a good percentage of that surgical expenditure, but also to significantly grow the market as most hair loss sufferers elect to avoid hair transplant surgery due to the invasiveness and variability associated with the procedure.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation) as well as its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries.

All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.

For more information, please contact:

CONTACT:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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VANCOUVER, BC – July 21, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (Frankfurt: P6P1), (“RepliCel” or the “Company”), a clinical-stage regenerative medicine company focused on the development of autologous cell therapies, is pleased that its RCH-01 product, for the treatment of androgenetic alopecia, is now cleared by the Japanese regulatory authorities for use in a clinical research study launching now in Japan.

The study, designed to involve 60 men and women with thinning hair caused by androgenetic alopecia, will be conducted at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama. Clinical endpoints will include measures of safety and efficacy based on hair fibre thickness and density.

As part of the Agreement between the companies, RepliCel’s team trained the clinical investigatory team on critical elements of both the patient biopsy procedure and injection of the cellular product into the patient’s scalp. Furthermore, the injector being used in this study mimics RepliCel’s patented, first-generation injection technology.

“We believe that Japan’s unique regenerative medicine regulatory and industry environment provides a unique opportunity to rapidly advance this product in their country. We are excited that RCH-01 has the potential to be launched in the Japanese market by Shiseido sooner than anywhere else in the world,” stated RepliCel CEO, R. Lee Buckler.

About RCH-01

Market: $3.5 billion was spent on hair loss treatments in 2015 according to the Washington Post, with $2.5 billion of this spent on surgical procedures according to the International Society of Hair Restoration Surgery. We believe RCH-01 has the potential to capture a good percentage of that surgical expenditure, but also to significantly grow the market as most hair loss sufferers elect to avoid hair transplant surgery due to the invasiveness and variability associated with the procedure.

About RepliCel Life Sciences

For more information, please contact:

CONTACT:

Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Japan’s Pharmaceuticals and Medical Devices Agency reviews RepliCel’s pre-clinical, quality, and manufacturing data for its non-bulbar dermal sheath (NBDS) platform

VANCOUVER, BC – April 25, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced that it met this month with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in Tokyo. The meeting was a formal consultation review of the company’s pre-clinical, quality, and manufacturing data related to its non-bulbar dermal sheath (NBDS) platform technology. This review is a required step in the process to obtain PMDA consent to perform a clinical trial in Japan.

“We have been very encouraged by the PMDA’s collaborative approach and yet the absolute high standards of safety they maintain”, stated R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. “The conduct of this consultation meeting moves the clinical-stage products (RCT-01 tendon repair; RCS-01 skin rejuvenation) being developed from our NBDS platform closer to the launch of Japanese clinical trials and partnerships”, he added.

Furthermore, each consultation performed by the PMDA at the formal request of a potential clinical trial sponsor, carries with it associated fees which are lowered for academic institutions, hospitals, and small/medium enterprises. Additionally all documentation created for the consultation must be provided in Japanese.

Without any known precedent for doing so, RepliCel, on the advice of CJ Partners Inc., applied for the reduced-fee designation based on its small size and the pre-revenue nature of its business. The company was successfully awarded a reduced fee status which represents approximately one-tenth of the otherwise applicable fees.

“To the extent that CJ Partners knows, this is the first time that a foreign regenerative medicine company has qualified for the reduced price status with the PMDA”, commented Colin Lee Novick, Managing Director of CJ Partners Inc.

“RepliCel continues to pioneer foreign participation in cell therapy development in Japan”, said Buckler. “We are committed to early commercialization of our products in Japan and entering into a Japanese-based partnership for each product in our cell therapy portfolio.”

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company for certain Asian countries.

All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. The Company has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.

For more information, please contact:

CORPORATE:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

MEDIA/INVESTOR RELATIONS:
Jacqui Specogna
Telephone: 604-248-8730 / js@replicel.com

Forward-Looking Statements

Certain statements in this press release related to the Program are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “will”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding the number of Warrant Holders that may participate in the Program, the use of proceeds and final regulatory approval. Such forward-looking statements should therefore be construed in light of such factors, and the Company is not under any obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Find full article here online, at The Asahi Shimbun.

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Conference brings together hair biologists, dermatologists, cosmetic scientists and leading biotech companies to discuss the advancement of knowledge in hair growth and research

VANCOUVER, BC – November 12, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that RepliCel’s Chief Medical Officer (CMO) and Chief Scientific Officer (CSO) – both founders of RepliCel’s technologies – will be presenting at the 9th World Congress for Hair Research taking place November 18-21, 2015 at the InterContinental Hotel Miami at 100 Chopin Plaza, Miami, Florida, USA. This year’s Congress theme is “Reflect, Rejuvenate, and REGENERATE,” with a program-focused goal of reflecting on current hair follicle regeneration knowledge, learning about the latest research in the field and developing new collaborations.

RepliCel CMO Dr. Rolf Hoffmann will be presenting on Saturday, November 21 with a presentation entitled, “Treating Alopecia and Beyond: How the hair follicle may be an ideal resource for cell-based therapeutics.” On the same day, RepliCel CSO, Dr. Kevin McElwee will present a talk entitled, “Hair Follicle Mesenchyme Cells Exhibit Immune Privilege and Can Improve Islet Allograft Survival.” Both presentations will include an overview of ongoing clinical and technical research relevant to RepliCel’s RCH-01 hair technology and its other products manufactured from hair follicle derived cells.

“Dr. McElwee and I are pleased to have the opportunity to present our data at this prestigious conference. We are proud to be involved in commercializing much of our work through RepliCel Life Sciences, Inc. which now has three products in clinical trials, all derived from the cells of the hair follicle, including RCH-01 as a treatment for androgenetic alopecia now in co-development with Shiseido Company,” stated Dr. Rolf Hoffmann, CMO of RepliCel Life Sciences Inc.

About WCHR
The World Congress for Hair Research is a comprehensive, international hair research meeting with the goal of highlighting new research, sharing experiences and discussing new directions for the advancement of knowledge in hair growth, hair and scalp disease and clinical care. This 4-day Congress includes presentations, full-exhibit programs, pre-Congress workshops, networking opportunities and company-sponsored satellite symposia. To learn more, visit: http://www.hair2015.org/

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The company’s product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s healthy hair follicles. The company has also developed a propriety injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Visit www.replicel.com for additional information.

For more information, please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

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Canadian companies driving global breakthroughs in regenerative medicine

By Kathryn Boothby

To read this article on the Financial Post website, click here.
CCRM – helping position Canadian companies at the centre of regenerative medicine around the world

Rapid advances in regenerative medicine are bringing the promise of curative solutions for chronic conditions closer to reality. Canadian companies are at the forefront of this revolution, paving the way for this country to be a standard-bearer of breakthrough treatments for patients around the globe.

Therapies using cells are potentially improving outcomes and reducing or eliminating side effects for such devastating diseases as diabetes, hemophilia, and critical limb ischemia, as well as conditions such as chronic tendinosis, damaged skin, and pattern baldness. New tools and technologies are also helping to put an end to bulky, obtrusive mechanisms to deliver life-saving treatments.

“We are at a powerful leading edge for medicine,” says Michael May, president and chief executive officer of the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto. “The ability to regenerate tissue will transform the treatment of diseases, quality of life, and the economics of health care.”

“Billions are being spent globally in the field of regenerative medicine on investment, research, development and sales,” says May. “Now, with clinical efficacy being demonstrated, we’re seeing more regulatory approvals and resulting mega-deals between small companies and large corporations.”

But where does Canada fit in the global picture? The discovery of stem cells in Canada in the 1960s sparked the worldwide use of bone marrow transplants for patients with leukemia and aplastic anemia. “This spawned an incredible research machine that made some important discoveries over the ensuing years. We are at a similar junction today,” he says. “We’re leading the science and have begun to leverage commercialization around the globe. The system is primed; we now need to fuel it with private investment to ensure Canada is at the centre of this emerging industry.”

CCRM is actively working to achieve that goal by coordinating access to bundles of technologies from around the globe; creating and supporting companies to further develop and commercialize those discoveries; and establishing relevant industry networks and accessible infrastructure. CCRM currently works with a 50-member industry consortium that includes therapeutic innovation companies, multinational pharmaceutical organizations such as Pfizer and Amgen, and infrastructure and tool companies such as GE Healthcare and Stemcell Technologies.

“Access to strong academic and industry networks enables us to now build a third key stakeholder group —an investor network,” says May.

That strategy is beginning to pay off for some of Canada’s cell therapy companies, including RepliCel Life Sciences Inc., Hemostemix Inc., and Sernova Corp.

RepliCel (TSX.V: RP) is driving multiple products in the regenerative medicine arena with three cell therapy products in clinical development, and a dermal injection device that promises to change the way any product is delivered in or under the skin, including the over $2-billion worth of dermal fillers injected annually.

“2015 is a pivotal year for the company,” says Lee Buckler, RepliCel’s vice-president, business and corporate development. “This is the year we moved all our cell therapy assets forward in clinical development, which sets us up for transformative catalysts over the next 18 months.” Earlier this year, RepliCel launched a Canadian trial for chronic tendinosis and just recently announced the launch of a dermatology trial in Germany. Topping off the trio is a trial for pattern baldness with commercialization partner Shiseido Company, which is expected to launch in Japan shortly.

RepliCel is one of a handful of foreign cell therapy companies with an active partnership in Japan. “Having Shiseido, one of the world’s largest cosmetic firms, as RepliCel’s partner for its pattern baldness product, has given us notable credibility in that market,” says Buckler, “and we are now engaging other companies in Japan about partnerships for our other products.”

“Partnering in Japan is at the top of our list because the government has expedited the process of developing cell-based therapies, making it possible to bring cell therapies to market faster there than any other regulated market in the world,” says Buckler.

Hemostemix (TSX.V: HEM) is currently undertaking an international phase-two, double-blind, randomized, placebo-controlled clinical trial to test the efficacy of a cell therapy to treat critical limb ischemia (CLI). CLI is characterized by insufficient blood flow to the lower limbs caused by blockages in small blood vessels. In North America alone, some four million people have the disease, and 25% will die from it. Currently, the only treatment is amputation.

The process involves collecting cells from a patient’s blood that are then manufactured into a cell therapy and delivered back to the patient. The company believes that the reintroduced cells create new blood vessels that restore blood flow and save the limb from amputation.

“CLI is a severe disease, threatening millions of people’s lives worldwide. We are running our clinical trials in leading international centers, including Canada, the U.S., South Africa, and soon in Taiwan,” says Dr. Elmar Burchardt, Hemostemix’ president and chief executive officer and former vice-president of regenerative medicine at Pfizer.

Sernova (TSX.V: SVA), a clinical stage company, is treating chronic, debilitating diseases such as insulin-dependent diabetes, hemophilia A and thyroid disease using a regenerative medicine approach through the placement of immune-protected therapeutic cells into an implanted pre-vascularized medical device. The company believes that the Cell Pouch System, about the size of a business card, creates a natural organ-like environment when placed under the skin and the cells release required proteins or hormones such as insulin, or Factor VIII potentially eliminating the need for chronic injections or infusions.

For diabetes, Sernova’s product — the device and cells implanted in humans — is being designed to mimic the pancreas where cells (islets) read blood sugar levels then release both insulin and other hormones into the bloodstream. The company has recently become a fully integrated pharmaceutical company as it has gained worldwide exclusive rights to a glucose responsive insulin-producing stem cell technology from University Health Network (UHN). The company has received grants from the National Research Council, Juvenile Diabetes Association and support from both the Canadian and Ontario governments to assist with its activities.

“If Sernova’s treatment leads to patients no longer having to take injections or deal with a cumbersome device, this could improve the quality of life for millions of people, reduce the debilitating side-effects of the disease, and cut health care system costs significantly,” says Dr. Philip Toleikis, Sernova’s president and chief executive officer.

“Canada imports close to 100% of our medical treatments,” notes May. “It would be much more exciting to be exporting our treatments and using our health care system to develop and deliver those products to patients around the world, all while improving the health of Canadians here at home.”

Canadian companies working in regenerative cell therapy have globally competitive technologies and great science. RepliCel, Hemostemix, and Sernova are all moving products through clinical trials at a time when big industry players are making investments in manufacturing, therapeutics and tools to facilitate the production of cells.

“While every company’s corporate strategy is different,” concludes RepliCel’s Buckler, “it is our corporate intention to build sufficient value in our assets, licenses, and royalty streams so that the company becomes a home-grown acquisition target thus contributing valuable assets to the growing appetites for regenerative medicine among the global multinational players.”

This story was produced by Postmedia Works on behalf of Market One Media Group for commercial purposes. Postmedia’s editorial departments had no involvement in the creation of this content.

To read this article on the Financial Post website, click here.

FINANCIAL POST ARTICLE – SPONSORED BY REPLICEL LIFE SCIENCES

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Click here to view the article on Cantech Letter

Vancouver-based RepliCel Life Sciences (TSXV:RP) concentrated on hair regeneration until 2011, participating in the $3 billion annual male pattern baldness industry. But when the far-reaching effects of its solution became apparent to its founders, RepliCel began expanding its offer to apply the technique of using cell therapy to encourage the healing of damaged or injured tissues to other body parts.

The company recently partnered with Tokyo-based cosmetic giant Shiseido, offering RepliCel access to the vast Asian market.

Cantech Letter talked to RepliCel as part of our “Five Questions” series. Our “Five Questions” Series runs all this week, posing the same five questions to up-and-coming Canadian innovation sector companies.

What does your company do?

RepliCel Life Sciences Inc. is a regenerative medicine company focused on developing autologous cell therapies for the treatment of musculoskeletal tissue injuries, aging and UV-damaged skin and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles.

RepliCel’s strategy is to license its assets to partners for late-stage development and commercialization. Shiseido, one of the world’s largest cosmetic companies, has an exclusive license for RepliCel’s pattern baldness product, RCH-01, in certain Asian countries including Japan, China and South Korea.

What problem are you trying to solve?

RepliCel is developing autologous cell therapies which address conditions caused by a deficit of the healthy, active cells required for normal healing and function.

RepliCel’s propriety injector device (RCI-02) is programmed to control depth, dose, and volume of the injection and allows for widespread injections across broad areas. In addition, RepliCel’s device has a built-in peltier element which numbs the skin just prior to injection eliminating the need for anesthetic. These features distinguish Replicel’s dermal injector from any others currently on the market.

How is your solution better than what is currently offered?

The regeneration of chronically injured tendon, the natural rejuvenation of the extra-cellular matrix under the dermis of those with aging or sun-damaged skin, and the regrowth of hair for those people suffering from pattern baldness attributed to androgenic alopecia are not conditions which can be resolved by currently available products or treatments.

How big is the market you are addressing?

The combined total addressable market size for pattern baldness, skin rejuvenation, tendon repair, and a next-generation dermal injector potentially valuable for any kind of dermal injection is understandably large – easily estimated at >$2 billion annually.

What will you be working to accomplish in the next year?

2015 is on track to be a transformative year for RepliCel as we move each of our assets into next-stage of clinical development. We anticipate accomplishing the following over the next 12 months:

-Clinical data from the RCT-01 (chronic Achilles tendinosis) trial in Canada and from
-Clinical data from the RCS-01 (aging and sun-damaged skin) trial in Germany
-Receipt of a CE mark clearing the RCI-02 dermal injector for sale in Europe
-Execution of a licensing partnership in Japan for RCT-01 or RCS-01
-Execution of a global licensing partnership for RCI-02 for select product(s)
-Launch of our phase 2 RCH-01 (pattern baldness) clinical trial in Germany
-Shiseido’s launch of its RCH-01 (pattern baldness) clinical trial in Japan
-Technology transfer complete to a contract manufacturing facility in North America

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Conference program to include presentations on the clinical development of RepliCel’s skin rejuvenation, hair regeneration, and tendon repair technologies

VANCOUVER, BC – June 5, 2015 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today that RepliCel’s technology founders and management will be attending the 23rd World Congress of Dermatology (“WCD”) 2015 held in Vancouver, British Columbia, Canada. This year’s congress will take place from June 8 – 13, 2015 at the Vancouver Trade and Convention Centre. The RepliCel team will be involved in multiple sessions spanning the length of this conference. Chief Scientific Officer, Dr. Kevin McElwee will be chairing a session entitled: “Hair Biology and its exploitation in health and disease” on Tuesday, June 9th from 8 – 10 AM PST in West 2015-107. Dr. McElwee will also be giving a poster presentation entitled: “Hair-follicle derived mesenchymal cells in cell therapy: multiple therapeutic applications” on Thursday, June 11th from 9 AM – 1PM PST. Chief Medical Officer, Dr. Rolf Hoffmann, will be coming from Germany to co-chair a session entitled: “Alopecia Areata” on Thursday June 11th from 2:30 – 4:30 PM PST in West 223-224. Also present at this conference will be RepliCel’s CEO David Hall, VP Business and Corporate Development Lee Buckler, and Director of Research and Development Dr. Hisae Nakamura.

“We are pleased Vancouver is host to this year’s World Congress of Dermatology and excited to be participating among the world’s leading experts advancing science and technology in dermatology. We congratulate the event organizers, and in particular Drs. Jerry Shapiro, Harvey Lui and David McLean, who were amongst the visionary founding group of our company, on putting together what promises to be an outstanding program and world-class event,” stated David Hall, CEO of RepliCel. “We look forward to the contributions of our Chief Scientific Officer, Dr. Kevin McElwee, and Chief Medical Officer, Dr. Rolf Hoffmann, the scientific co-discoverers of RepliCel’s technology, in the conference at sessions highlighting various aspects of RepliCel’s hair follicle-derived technologies.”

About World Congress of Dermatology
WCD is the world’s oldest and longest-running international dermatology meeting, with the first Congress in 1889. It is presented by the International League of Dermatological Societies and will feature over 200 scientific sessions featuring experts and companies in the medical, surgical and cosmetic dermatological fields. The WCD’s focus is to bring the interests and priorities of the dermatology industries to an international, professional focus. For more information about the congress, visit The World Congress of Dermatology website.

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China, and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a proprietary injection device optimized for the administration of its products and licensable for use with other dermatology applications. The Company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696 / tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693 / lee@replicel.com

This press release contains forward-looking information. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: approval to conduct clinical trials; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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RepliCel Targets Low-Risk, Near-Term Opportunities in Regenerative Medicine

By: Gail Dutton

The regenerative medicine company RepliCel Life Sciences is developing potential cures for chronic tendinosis, damaged or aging skin, and pattern baldness by reseeding affected areas with specific cell populations isolated from patients’ own healthy hair follicles.

RepliCel is picking the low-hanging fruit of regenerative medicine—low technological risk, underserved markets, clear clinical indications. Furthermore, commercial success is not dependent on successful reimbursement negotiations.

“On the technical level, we’re not asking these cells to do anything other than what they naturally do, or be anything more than they are,” CEO David Hall says. “These are adult, somatic cells derived from the patient which we simply isolate and grow. We’re not differentiating, genetically modifying, or manipulating these cells in any way.

At present, there is no therapy to treat the underlying causes of tendinosis, which include a deficit of collagen-producing tenocytes (fibroblasts). RepliCel’s approach to the treatment of tendinosis uses injections of cultured autologous, collagen-producing, nonbulbar dermal sheath cells into the injury site to stimulate tendon regeneration

From the scientific and manufacturing perspective, RepliCel is using the hair follicle as the cell source because the cells are simple to collect, grow well in culture, and are both relatively naive and highly functional. On a clinical level, the company is simply addressing a deficit of active cells in the patient by local delivery of cells shown to function in ways needed to solve a human condition such as tendinosis or pattern baldness.

“The cells are injected in ways and places that largely eliminate any concerns around in vivo cell migration,” explains Hall. “[This approach ensures] enough cells stay in situ and viable to affect a sustained effect.”

Indications

For tendinosis—a disrupted healing cycle of the tendon—nonbulbar dermal sheath (NBDS) fibroblast cells are isolated from a biopsy of hair follicles taken from the back of the scalp. After these cells are replicated, creating populations of millions of cells, they are injected into the wound site to jump-start the disrupted wound repair.

In early-stage trials, clinical advisory board member David Connell, M.D., used a similar approach with tendinosis patients who had been failed by other therapies. The NBDS approach returned these patients to painless, near-normal function.

In the next 18 months, Hall says he expects to conclude a Phase I/II study at the University of British Columbia involving 28 participants. As yet, there is no approved therapy that treats the underlying cause of this chronic condition.

This same NBDS platform technology also may be used to repair damaged and aging skin. RepliCel filed a clinical trial application for Germany in February.

Phase II trials to treat baldness—specifically, androgenetic alopecia—will begin this year. For this therapy, dermal sheath cup (DSC) cells are isolated from the base of the hair follicle, replicated into the millions, and injected to the area of thinning hair.

“DSC cells are responsible for maintaining the number of dermal papillae cells, which directly corresponds to the hair thickness,” Hall explains. “We are simply delivering a volume of androgen-insensitive DSC cells into an area where androgen-sensitive DSC cells have disappeared … to restore the normal hair follicle cycle.”

RepliCel’s autologous cell therapy utilizes dermal sheath cup (DSC) cells to treat androgenetic alopecia. DSC cells are responsible for the regulation of the volume of dermal papillae (DP) cells, which are responsible for the thickness and growth of a hair fiber. Another RepliCel technology uses nonbulbar dermal sheath (NBDS) fibroblast cells to treat tendinosis.

In animal studies, this approach grew hair on the feet of mice (which have no hair follicles there). When these cells were injected into their ears, the healthy cells migrated into resident hair follicles, making that hair thicker.

In humans, this approach could address existing hair follicle damage. “This is our longer-term program,” Hall stresses. RepliCel will begin a clinical trial in Germany this year involving 160 patients. Hall says results from RepliCel’s Phase I and Phase II clinical trials for chronic tendinosis and UV-damaged/aged skin are expected in 2016.

Manufacturing and Delivery

RepliCel currently uses industry-standard fetal calf serum in its manufacturing process, but is validating a serum-free process. “This is a distinguishing commercial step,” Hall asserts. “[It] adds value to our therapeutics program.” Hall notes that RepliCel anticipates licensing the process.

RepliCel is also investigating the potential of using its cells in an allogeneic setting. Hall says that a successful licensing effort could enhance both the business model and the value of company assets.
RepliCel also is developing a dermal injector to ensure controlled, consistent delivery of the cells to the skin and scalp. RepliCel expects that this device will control cell volume and delivery depth while minimizing shear force to the cells.

“We have also incorporated a Pelletier element into the tip, which reduces or removes the need for pre-injection anesthetics,” Hall informs. This second-generation injector is available for licensure. RepliCel plans to file for the CE mark in the latter half of 2015.

Partnerships

RepliCel already has a partnership with Shiseido in Japan to co-develop and commercialize RepliCel’s RCH-01 technology as a therapy for thinning hair in China, South Korea, and the ASEAN nations. RepliCel is actively pursuing similar geographically focused licensing and co-development partnerships for its other products.

It also is commercially active in Japan, where recent changes to Japanese regulations for regenerative medicine “have dramatically changed the pathway toward revenue generation,” Hall remarks. Those changes allow products that have demonstrated safety and potential efficacy in early-stage trials to gain conditional marketing approval. That lets them be sold and reimbursed up to seven years before being subjected to a final marketing approval review.

“In the current Japanese environment, we can generate data while simultaneously generating revenue and continuing to develop the same technology in the West,” Hall confides. He suggests that as a result of these regulatory changes, Japan will become important as a test bed for regenerative medicine.

RepliCel’s business model seems well-suited to Japan’s new regulatory stance for regenerative medicine. “We’re built to discover, validate, and license,” Hall states. “Commercialization is done with partners.”

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To read the article on Stockhouse click here

Until 2011, RepliCel Life Sciences (TSX: V.RP, Stock Forum) was engaged in the business of hair regeneration, developing treatment solutions for those suffering from pattern baldness. Compared to other entities within the space, RepliCel was pursuing a minimally invasive treatment with potentially permanent results. This innovative process involved growing cells extracted from the patient’s healthy hair follicles to stimulate growth in areas experiencing hair loss due to androgenic alopecia.

The hair loss treatment space, like the progressive condition at its base, is monumentally huge. With 40% of American males experiencing pattern baldness by the age of 30, it is of little surprise that the hair loss treatment market, according to a 2013 study conducted by the International Society of Hair Restoration, rakes in $3.0 billion annually.

RepliCel was unique in its offering as other treatments for hair loss such as hair transplants, covers like weaves and toupees, and medicated topical creams like Rogaine were respectively limited, noticeable and temporary. Stem cells have also been touted as a remedy for hair loss, but the research is far from complete and this division of scientific study is heavily regulated, creating a bottleneck between tech development and the shelf.

The ability to safely extract healthy cells from the dermal sheath cup of the hair follicle and grow those same cells in a lab environment, gave RepliCel a virtually limitless method to regenerate someone’s head of hair using their own cells with a science that would take years instead of decades to bring to commercialization.

Soon after David Hall joined the company as CEO, they embarked on an expansion of applications of this amazing family of cells. By utilizing a different cell population from the hair follicle – the non-bulbar dermal sheath fibroblast cell group – the company also found opportunity treat other conditions such as tendinosis, a chronic degeneration of the tendon due to aging and injuries, by the injection of these active fibroblasts.

Another condition treatable by the aforementioned cell group is skin damage caused by aging, UV exposure and lifestyle choices which results in wrinkles and sagging as the dermal layer loses its elasticity. Injection of the active collagen-expressing fibroblasts is designed to reverse this degenerative process.

This addition in corporate direction enhanced the company’s potential long-term profitability but also diversified its attentions and capacity. While the company dealt with growth media issues it had to resolve on the manufacturing of the pattern baldness product, Replicel’s market momentum began to tread water as investors lost interest in what was otherwise a promising venture. The company has worked hard to bring this multi-pronged beast under control and in the last 18 months has enacted initiatives which have brought schedules back online, powering a cycle of trials that will see major advances in commercialization of all three of its proposed treatments.

On top of the bio-med side, the company has also developed a patent-pending state-of-the-art delivery system for the above treatments which in and of itself bears tremendous potential for another lucrative avenue of revenue generation. This dermal injector allows for programmable depth and dose with built-in freezing replacing the need for anaesthetic. Its leading-edge design is expected to disrupt the dermal filler market which in 2013, according to the American Society of Plastic Surgeons, consisted of almost 6.0 million injected procedures and over $3.0 billion in revenue. Good news considering that RepliCel expects the approval for this device in 2016.

For those interested, below is a graphed timeline of testing and development for the company’s current pipeline:

That’s a healthy plate of activity and one might surmise RepliCel could topple under the weight of its multi-faceted offerings, but management has been keen to design a corporate philosophy that focuses on value creation and IP rather than the mechanics of mass manufacture and commercial product launches. This will allow the company to license out its technology to multiple partners for a global reach not easily attained by vertically modeled bio-tech firms and to continue its R&D efforts enhancing current offerings as well as developing new marketable technologies.

Partnerships are another strong point for RepliCel as the company has teamed with 140 yr-old cosmetic giant Shiseido Company based in Tokyo. Shiseido, the third largest cosmetics company on the planet, has signed an agreement with RepliCel, giving Shiseido exclusive geographic licensing for RCH-01 (treatment of pattern baldness) in certain Asian countries such as Japan, China and South Korea. As a result of the agreement, both companies will share their respective improvements to the technology while individually carrying out of human clinical trials. Due to the recently enabled legislation in Japan which offers potential early access to the market, RepliCel has embarked on a focused Japanese licensing program for its fibroblast based treatments for tendinosis and ageing and UV damaged skin.

The company has also partnered with the University of British Columbia, Department of Dermatology and Skin Science to conduct research on the biomechanical and functional characteristics of hair follicles. This association with reputable academia provides a boatload of credence for RepliCel’s innovative tech and gives hope for future potentially commercial discoveries.

Meanwhile, as the trial results continue to come in, RepliCel is building a solid foundation for taking the company to the next level and its family of investors may see the lucrative fruition of its efforts as early as 2016. As of yet, the company’s story is relatively unknown, but as it continues to progress through these trials and development phases, it is becoming increasingly apparent that it is wildly undervalued. The challenge will be if management can continue to keep control of its corporate ship, meet those necessary milestones and initiate growth to capture a long-term slice of an already lucrative sector. In the end, 2015 will be the proving ground for RepliCel’s long-term success. I will be watching them closely over the next 12 months.

Read more at Stockhouse

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To read the full article on The Province newspaper website click here\\n

\\n

A Vancouver-based anti-aging company is betting that the fountain of youth flows with antifreeze produced by an Antarctic fish.

\\n

Sirona Biochem has synthesized compounds from glyco-proteins made by the Nototenioid that enable the homely but hardy fish to survive in sub-zero temperatures.

\\n

The company has created an age-busting technology to protect people’s skin and restore its youthfulness, says Attila Hajdu, Sirona’s chief business development\\n officer.

\\n

“We’ve developed an anti-aging compound that has been scientifically proven to extend cell life and prevent cell death,” Hajdu says.

\\n

“It’s remarkably exciting.”

\\n

Sirona belongs to a group of B.C. age-busters at the cutting edge of the global push to help people live longer.

\\n

Many B.C. residents would be “shocked and dumbfounded” to learn that companies in their own backyard are making real progress in extending people’s lives,\\n says Paul Drohan, president-CEO of

\\n

LifeSciences B.C., a Vancouver-based industry association.

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Not content to simply give people more years, B.C. biotech companies are responding to boomers’ desire to age gracefully by staying healthy and active,\\n Drohan says.

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“The idea is to keep people on their bikes and paddle boards longer, to keep them running longer, and looking good while they’re doing it,” Drohan says.

\\n

It’s no accident B.C. companies are at the leading edge of anti-aging research.

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The province has top-notch biotech talent and a good track record for “translation” — taking lab discoveries and turning them into commercial products,\\n Drohan says.

\\n

The province scored an early victory in the anti-aging war in the late 1980s when Vancouver ophthalmologist Jean Carruthers and Alastair Carruthers, her\\n dermatologist husband, discovered the cosmetic powers of a toxin called Botox in easing lines and wrinkles.

\\n

B.C. seniors’ appetite for anti-aging products or therapies has only grown.

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The province already has the longest average life expectancy in Canada — 84 for women, versus the national average of 83; 80 for men, against the\\n national average of 79.

\\n

“We probably have one of the most active elderly populations in the country,” Drohan says.

\\n

“They’ve made sure they’ve lived a healthy life and they’re interested in advances in anti-aging and regenerative medicine.”

\\n

Vancouver is a pinpoint in the global anti-aging market. U.S.-based firm BCC Research estimates that people over 65 will make up 12 per cent of the world’s\\n market by 2030, up from seven per cent in 2010.

\\n

As the planet’s population ages, the global market for anti-aging products is soaring.

\\n

BCC expects the worldwide market for anti-aging cosmetic and pharmaceutical products to climb to $345.8 billion US in 2018 from $249.3 billion in 2012.

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The related market for regenerative medicine, which aims to restore functional ability to tissues and organs, should explode to $67.6 billion US in 2020\\n from $16.4 billion in 2013, according to a separate report.

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B.C.’s anti-aging companies want to grab a piece of this action.

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But the field is fraught with risk as companies spend years demonstrating to regulators their products are safe and effective, Drohan says.

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“Some discoveries will turn into huge commercial successes and some, unfortunately, will not prove their end points,” he says.

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It can take 10 years for a product to pass clinical trials and be approved by regulators as being market-ready.

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Following are four B.C. companies that already have anti-aging products or are well along the way to putting them on the market.

\\n

BALDNESS TREATMENT IN THE WORKS\\n

RepliCel Life Sciences wants to turn back the clock on how you look and how you feel.

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The Vancouver-based company is exploring the frontiers of regenerative medicine to treat injured tendons, pattern baldness and skin damaged by sun and\\n age.

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The world’s scientists have advanced from using chemical compounds to proteins and antibodies in their bid to reverse age-triggered wear and tear, says\\n Lee Buckler, RepliCel’s vice-president of business and corporate development.

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“We are the next wave of biotechnology. We use cells as medicines. We call this cell therapy,” Buckler says. “We’ll not only keep people looking younger\\n but acting younger. It’s as much a matter of keeping the guy on the golf course as it is looking good while he’s golfing.”

\\n

At the core of RepliCel’s age-busting technology are cells called fibroblasts extracted from a patient’s own hair follicles. Fibroblasts produce Type 1\\n collagen, a protein that helps the body repair skin and connective tissue.

\\n

“It’s like personalized medicine. You don’t have to pump yourself full of synthetics anymore. This uses your own cells.”

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Injections of fibroblasts have been proven in the lab to help tendons repair themselves, reduce wrinkles and tone up skin, Buckler says. A different set\\n of cells extracted from follicles is used to regenerate hair.

\\n

The company has embarked on an aggressive program of trials on human subjects to prove to health regulators its approaches are safe and effective.

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The need for three sets of trials for each therapy means RepliCel’s therapies are several years away from reaching the North American market, Buckler says.

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RepliCel scored a coup in 2013 when it formed a partnership with Japanese cosmetic giant Shiseido. That partnership, and Japanese regulatory changes, mean\\n RepliCel’s pattern baldness treatment will likely reach the Japanese market sooner than anywhere else, Buckler says.

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Formed in 2010, RepliCel trades on the TSX venture exchange and employs about a dozen people.

\\n

SAVING FACE\\n

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The first battleground in Sirona Biochem’s fight against aging is the mirror.

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The Vancouver-based company is developing anti-aging products based on the antifreeze produced by an Antarctic fish to protect and regenerate human skin,\\n says Attila Hajdu, the company’s chief business development officer.

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“Everyone looks in the mirror. If we help make them happier with what they see then we’re improving their lives,” Hajdu says.

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The chemical compounds that Sirona has synthesized based on the fish’s glyco-proteins go beyond their power to lighten skin and protect it from the impact\\n of age and sun damage.

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The synthesized compounds’ cell-preserving powers also mean they can be used in organ and tissue transplants, Hajdu says.

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The company has licensed its compounds to companies around the world in return for fees and royalty payments.

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Sirona, which began in 2009, employs 15 people and trades on the TSX venture and Frankfurt stock exchanges.

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It conducts research at a laboratory in France.

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FUELLING STEM CELL RESEARCH\\n

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Vancouver-based Stemcell Technologies hands global scientists the tools they need to help people live longer.

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Stemcell has become Canada’s largest biotech company by selling nutritious soup — technically, it’s called “tissue culture media” — that scientists\\n need to grow specialized stem cells for anti-aging research.

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“We provide the picks and shovels for the regenerative medicine gold rush,” says CEO and owner Allen Eaves.

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Scientists, who obtain stem cells from sources such as skin and blood, use the company’s products to research cell therapies for everything from diabetes\\n to Parkinson’s disease.

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Tissue engineering to regenerate organs is an area of intense research.

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“When you have kidney failure, ideally, you will be able to engineer and construct a replacement kidney using a patient’s own cells rather than looking\\n for a donor,” Eaves says.

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Eaves founded the company in 1993 as a spinoff from the Terry Fox Laboratory at the B.C. Cancer Agency. It employs 650 people, 500 of whom are in Vancouver.

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Stemcell sells products to about 70 countries. It has annual revenues of about $100 million and has been profitable since its launch. The company has committed\\n $350 million to research and development over the next 10 years.

\\n

HALTING A RENEGADE ENZYME\\n

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ViDA Therapeutics is working to help people shake off the effects of age by sticking a sock in the mouth of one of the body’s trickiest frenemies.

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The immune system produces an enzyme called granzyme B to target and kill infected cells. So far, so good.

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But several years ago researchers at Vancouver’s St. Paul’s Hospital found high levels of granzyme B outside of cells in aged and damaged human skin. They\\n also discovered high levels of the enzyme in the occurrence of other ailments such as rheumatoid arthritis, fibrosis and heart disease.

\\n

Knowing they were on a promising path, research scientist and University of B.C. professor Dave Granville joined forces with Vancouver biotechnology veteran\\n Alistair Duncan in 2008 to launch viDA.

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Since then, viDA’s research team has developed a library of molecular compounds to inhibit granzyme B.

\\n

“Granzyme B is running amok and causing damage from rheumatoid arthritis to heart conditions to neural inflammation,” Duncan says. “If you picture granzyme\\n B as a Pac-Man that goes around gobbling, we stick a sock in its mouth so it can’t gobble anymore, allowing the healing process to begin.”

\\n

Privately owned viDA is focused on research to develop a cream to tackle skin aging and discoid lupus erythematosus, an auto-immune disease aggravated\\n by sunlight that can cause facial scarring. Pop musician Seal has this condition.

\\n

ViDA is also exploring how its granzyme B inhibitors may be used to treat other diseases such as aneurysms and chronic obstructive pulmonary disease.

\\n

Getting a skin treatment through the regulatory pipeline to market may take seven to eight years, Duncan says.\\n
Given that granzyme B levels rise with age, baby boomers may wish to pay attention.\\n
pluke@theprovince.com\\n
twitter.com/ProvMoney\\n
© Copyright (c) The Province

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To read the article on the Financial Post website click here.\\n

\\n

Canada and Japan are taking distinctly different but complementary paths in the development of a regenerative medicine industry within their borders. While\\n their paths may differ, their activities are having a profound impact on the future of a global industry that is poised for exponential growth.\\n
Dr. Lesley Chan, Cell Manufacturing Development Scientist at CCRM, culturing cells\\n

\\n

Japan’s commitment to regenerative medicine leadership has been fuelled by Prime Minister Shinzo Abe’s vision for revitalizing the country’s economy. That\\n economic revival includes policies to support the development of a robust, world-leading regenerative medicine industry in Japan, including US$1-billion\\n in funding for stem cell research over 10 years.

\\n

While the Japanese initiatives are in part driven by national economic interests, they are fundamentally about bringing new medicines to a significantly\\n and rapidly aging Japanese demographic.

\\n

“Japan is looking to establish leadership in the regenerative medicine industry by encouraging domestic innovation and enticing foreign companies to develop\\n products in Japan by bringing foreign therapeutics to the Japanese market”, states Shinichi Muto, Chief Japan Representative for Euro Pacific Canada,\\n Inc. “The mission of our nation’s leadership is to pave the way for real, practical, breakthroughs in regenerative medicine. My firm is actively working\\n with companies outside Japan, like RepliCel Life Sciences and others, to build three-way partnerships between Japanese investors, strategic partners,\\n and therapeutic developers.”

\\n

“The regenerative medicine and cell therapy field is changing rapidly around the world,” says Michael May, Chief Executive Officer of the Centre for Commercialization\\n of Regenerative Medicine (CCRM) in downtown Toronto. “What is happening in Japan is one example of how momentum is building in this industry. Corporate,\\n technological, financial and clinical developments are happening very, very quickly.”

\\n

Regenerative medicine aims to harness the power of cells, biomaterials and molecules to repair, regenerate or replace diseased cells, tissues and organs.\\n It has the promise to treat, manage and perhaps cure some of the most devastating and costly diseases or chronic conditions in the world today.

\\n

A key component of Japan’s strategy is changing the regulatory policy around the oversight, approval, clinical development and manufacturing processes\\n related to cell-based therapies. “For those in the industry, this is a leading initiative that promises to dramatically change the regenerative medicine\\n landscape,” May says. “Japan is revolutionizing regulatory approval in order to become a ‘stem cell nation’.”

\\n

Canada has its own leadership role to play in terms of its strength in regenerative medicine science, he adds, “Canada has some very novel and valuable\\n strategies in play around regenerative medicine that will benefit immensely in light of Japan’s movement.”

\\n

CCRM is playing a key role in commercializing the wealth of regenerative medicine science and intellectual property available in Canada. This is being\\n achieved either by establishing new companies or finding partners to develop technologies on their behalf. Since its inception in 2011, CCRM has established\\n ties with academia, created a formal industry consortium of more than 40 companies from around the world, and gained six core Canadian institutional\\n partners.

\\n

Consortium members representing key sectors of the regenerative industry include the McEwen Centre for Regenerative Medicine,\\n a world-renowned centre for stem cell biology and regenerative medicine to treat conditions such as heart disease, diabetes, respiratory disease and\\n spinal cord injury. Canada is also home to the Canadian Stem Cell Network,\\n one of the most prodigious producers of preclinical stem cell research and publications.

\\n

CCRM to-date has performed due diligence on 200 cell therapy technologies from Canada and around the world. These include work by Canadian leaders such\\n as Induce Biologics, Sernova, TRT, RepliCel Life Sciences, Insception Lifebank, Octane, Northern Therapeutics, Interface Biologics, Stemcell Technologies,\\n Actium Research, Hemostemix and more.

\\n

Now the focus is on building a third network which is one of investors, May says. “The plan is to launch investment vehicles specifically focused on regenerative\\n medicine to finance commercial opportunities in Canada. This final piece is really important in supporting commercialization and creating manufacturing\\n capability in Ontario. When this happens, Canada will hold a unique leadership position in the world.”

\\n

CCRM is a world-class example of the efforts to create pathways for regenerative medicine commercialization, says Lee Buckler, Vice President, Business\\n and Corporate Development, for RepliCel Life Sciences (TSXV: RP) in Vancouver. “They are really bringing the whole industry to Canada by creating an\\n infrastructure for great research, development, production, and commercialization.”

\\n

RepliCel is a regenerative medicine innovator that has been among the first in the world to create formal ties with Japanese industry to leverage this\\n rapidly emerging opportunity. In 2013, it signed a major deal with Shiseido Company for commercialization of its autologous cell therapy (produced\\n using cells harvested from the patient’s own hair follicles) for treating pattern baldness. The agreement granted an exclusive license for RepliCel’s\\n most advanced product, RCH-01, to Shiseido for certain Asian countries.

\\n

Mr. Youichi Shimatani, Shiseido’s Chief Corporate Officer for Research and Development commented, “Creating beauty in everyday life is the mission of Shiseido.\\n To alleviate suffering of people with alopecia, we have dedicated many years to hair research. Using the knowledge and technologies acquired from our\\n research activities, Shiseido is currently preparing to launch an RCH-01 clinical research study for the treatment of pattern baldness under the supervision\\n of key clinical opinion leaders of hair research in Japan.” In his opinion, “Japan’s new Regenerative Medicine Law allows industry partners like Shiseido\\n to take part in clinical research under clinical guidance to develop new regenerative therapies. We hope that our efforts will lead to further promotion\\n and advancement of regenerative medicine in Japan.”

\\n

RepliCel holds a unique and strong competitive position in Japan, Buckler notes, because the deal with Shiseido was signed shortly before Japan’s new regulations\\n were finalized in November 2014.

\\n

He says RepliCel ranks as one of the few foreign cell therapy companies with a Japanese partner, and one of an even smaller group with an active manufacturing\\n footprint in Japan. “We believe we are also one of the first foreign cell therapy companies poised to initiate a clinical trial with its Japanese partner\\n under the new regulations.”

\\n

The company is also actively engaged with investors and potential partners to establish similar partnerships for other products in its pipeline for orthopedic\\n (tendon repair) and dermatological (skin rejuvenation) applications.

\\n

Buckler believes Canada’s deep roots in regenerative medicine, combined with the collaborative efforts on the part of CCRM, bode well for the prospects\\n of companies such as RepliCel that are pursuing global commercialization opportunities.

\\n

While Japan is not the sole focus of CCRM’s global collaboration efforts, May says it is a cornerstone to Canada’s future as a leader in regenerative medicine.\\n “One of the most revolutionary things Japan has done is create new pathways for regenerative medicine that allow cell therapy companies to get conditional\\n approval and bring their product to market more quickly. Expediting market access has created a tremendous motivation for companies to bring technologies\\n into Japan for development and commercialization. Investors for their part see the same opportunity and are looking for ways to build on this momentum.”

\\n

This momentum is indicative of the interest being generated in investment in cell therapy research globally, May says. “CCRM’s networking efforts with\\n other global centres of excellence, and new regulatory pathways in countries such as Japan, are wonderful examples of how firms are working in multiple\\n jurisdictions to bring potentially life-saving products to market.”

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VANCOUVER, BC – December 22, 2014 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced today the publication of a paper out of the University of Calgary in conjunction with co-authors from Kyoto University and the University of North Carolina, which further validates the company’s ongoing clinical research using dermal sheath cup (DSC) cells to reverse the effects of pattern baldness.

The paper entitled “Hair Follicle Dermal Stem Cells Regenerate the Dermal Sheath, Repopulate the Dermal Papilla, and Modulate Hair Type” published in the peer-reviewed journal Developmental Cell (31, 543-558, December 8, 2014) (http://dx.doi.org/10.1016/j.devcel.2014.10.022) summarizes research involving in vivo fate mapping done in an attempt to link hair loss to the roles and fate of various cell populations in and around the hair follicle.

The authors conclude that “[t]he findings have direct implications toward understanding the pathological mechanisms that underlie such hair loss and identify an endogenous source of cells that may be targeted to restore DP [dermal papilla] numbers and reverse hair follicle growth arrest.“

The study identified a ‘bipotent stem cell’ within the hair follicle tissue structure (a type of dermal sheath cell likely resident in the dermal cup) which the authors believe is responsible for generating new DP cells at the onset of each hair growth cycle and is directly linked to hair growth. Specifically, the paper states: “Our data strongly supports this idea and shows definitively that new DP cells are sourced from self-renewing, bipotent hfDSCs [hair follicle dermal sheath cells] residing in the dermal cup.“

It is this population of cells which is the subject of an extensive intellectual property portfolio held by RepliCel including a number of issued and pending patents. RepliCel’s RCH-01 product in development for the treatment of pattern baldness has successfully completed phase 1 clinical testing for safety and is being prepared for a phase 2 clinical trial in 2015.

“Our team has reviewed the publication with great interest,” stated RepliCel CEO, David Hall, “and we applaud the design of the research and its conclusions. It is credible validation of the science behind the cell population and technology covered by RepliCel’s intellectual property based on our team’s research and discoveries going back now over a decade. The authors concluded that a hair follicle dermal sheath cell which we describe as a dermal sheath cup cell has important implications toward restoration of hair growth after injury, disease, and aging.”

About RCH-01 Treatment for Pattern Baldness
RCH-01 is an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia. A phase 1 study was completed to assess the local (at treatment sites) safety profile of injections of the product at six months post-injection compared to placebo. The absence of any significant adverse events and preliminary signs of efficacy at a six-month interim analysis were sufficient to provide the company with the requisite safety information to begin preparing the regulatory filing for a Phase 2 clinical trial.

The phase 1 RCH-01 clinical trial, RepliCel’s intellectual property portfolio, and the associated science behind both, were sufficient to motivate Shiseido Company (the fourth largest cosmetics company in the world) to enter into a collaboration and technology transfer agreement with RepliCel for its autologous dermal sheath cup cell technology for treating pattern baldness (RCH-01). The agreement gives Shiseido an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Shiseido and RepliCel will collaborate on the continued improvement of the technology and will conduct human clinical trials in each of their territories with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair. In addition to RepliCel’s proposed phase 2 clinical trial in Germany for the treatment of androgenetic alopecia expected to launch in 2015, Shiseido also anticipates launching and funding a clinical trial in Japan in 2015.

RepliCel’s proposed Phase 2 trial will enroll 160 male subjects in good health with mild to moderate androgenetic alopecia. DSC cells will be isolated from a small punch biopsy taken from the back of the subject’s scalp. These cells will be replicated and then reintroduced into balding areas on the subject’s scalp. After injections are performed, subjects will return to the clinic for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well safety. Participants will remain in the trial for approximately 39 months.

About RepliCel
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The Company’s product pipeline is comprised of multiple clinical trials anticipated to launch through Q1 2015 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

MEDIA:
Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com

INVESTOR RELATIONS:
Lee Buckler, VP Business & Corporate Development
Telephone: 604-248-8693
lee@replicel.com

This press release contains forward-looking information that involve various risks and uncertainties regarding future events, including statements regarding our approach and our technology, expected and planned upcoming milestones and events, and the timing of trials. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of RepliCel. There are numerous risks and uncertainties that could cause actual results and RepliCel’s plans and objectives to differ materially from those expressed in the forward-looking information, including: approval to conduct clinical trials; approval from the University of British Columbia’s Clinical Ethics Review Board; delays enrolling clinical trial participants; negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, RepliCel does not intend to update these forward-looking statements.

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To read the full report, click here: R. Lee Bucker on RepliCel Life Sciences

Regenerative medicine and cell therapies hold possibilities for achieving near miracles in a multitude of indications, from life-saving treatments to aesthetic applications. RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB) is tackling a mix of medical and cosmetic issues that include hair regeneration, repair of painful and debilitating tendon injuries and rejuvenation of damaged skin. In this interview with The Life Sciences Report, R. Lee Buckler, the company’s new vice president of business and corporate development, discusses his firm’s innovative technology platform and the upcoming milestones that could affect its shares.

The Life Sciences Report: Lee, you’ve made a recent career change and are now an executive at RepliCel. Tell us about that.

R. Lee Buckler: As of Oct. 7, I have been appointed vice president of business and corporate development for RepliCel Life Sciences Inc., which is engaged in development of cell-based regenerative medicine therapeutics in Canada, Europe and Japan through our licensing partner, Shiseido Company Ltd. (4911:TSE). I found RepliCel to be a very interesting company poised to go on an exciting run, and that enticed me to join the team.

TLSR: Prior to your work with RepliCel, what experience had you had in the cell therapy industry?

RLB: In 2000, I left the practice of law to join Allen Eaves in the Stem Cell Technologies group of companies, where I ran a company called Malachite Management Inc. In 2006, I was recruited by Progenitor Cell Therapy to run its business development, marketing, communication and sales before the NeoStem acquisition.

In 2008, I founded my own consulting firm, called the Cell Therapy Group (CTG), which focused exclusively on the cell therapy industry. In the early days, we did some communications work for clients, but for the bulk of my tenure with CTG, we were involved in a wide range of planning and business development work. Some of it was transactional, but other aspects included market and competitive intelligence, building strategies, identifying partners, targeting partners, engaging in partnership discussions on behalf of clients and the like. I also worked with fund managers and investors through education, namely technology and platform explanations.

“RepliCel is a very interesting company poised to go on an exciting run, and that enticed me to join the team.”

Over the past year, I worked as a consultant and on the board of directors positioning TheraVitae Inc. (private) for a merger with a company listed on the Toronto Venture Exchange. The merger is expected to complete in early November, and the company will be renamed Hemostemix Inc. I helped TheraVitae raise several million dollars as part of that process. Being on the road giving presentations to prospective investors is a new skill set for me, but I’ve found I really enjoy this side of the business.

TLSR: You are an attorney by training, but I see from your curriculum vitae that you did a couple of stints as a medical laboratory technician while you were still in law school. Is that what led you to the life sciences field?

RLB: Yes. I always joke with people that I didn’t get to the cell therapy/regenerative medicine industry through education—I got here more by osmosis. I was not a silver spoon kid; I had to work my way through school. So while I was studying to be an attorney, I ended up working in the lab of a leading cardiovascular investigator, who was involved in some clinical trials at the time. I was mainly doing grunt work, but it exposed me to an environment where people were extremely dedicated to their sciences and to doing something novel. I was exposed to the excitement that builds when people truly believe what they’re doing could revolutionize the way people are treated.

I’ve always felt a little bit like an outsider in an industry of people who belong here. While that may feel uncomfortable from time to time, it also affords me a unique perspective that others don’t have. While others in the industry tend to focus on vertical specialties, I’ve come to specialize in a macro view of this industry. My focus has been very horizontal, which gives me a perspective of the industry that not many people are able to see.

TLSR: What kind of work has RepliCel been doing in the cell therapy field?

RLB: When CEO and President David Hall took over the company in 2011, it was built around hair regeneration. That is still an important part of our portfolio; however, he had a vision for broadening the technology and building a platform, which the company has now executed.

We are preparing to launch a very significant Phase 2 trial using our RCH-01 (dermal sheath cup [DSC] cells) for hair regeneration. This is a cellular injection—a cell transplant rather than a hair transplant—and is an important evolution because hair transplant is limited by three very significant factors. First, when transplanting hair follicles from one location on your scalp to another, there are only so many follicles available to harvest. With a cell transplant, there is no limit to the number of cells we can grow to use in regenerating poorly functioning hair follicles. Second, hair transplantation only achieves a satisfactory result when performed by a gifted surgeon, of which there are few. A simple cell injection takes the art out of the procedure—particularly when combined with our proprietary injection device designed to optimally deliver the cells into the scalp. Finally, hair transplantation is not an option women find attractive for a number of reasons, and a significant population of women suffer from hair loss.

TLSR: How is RepliCel working to ensure this therapy will be effective in both the short and long term? What prevents the dermal sheath cells from ceasing to grow hair once they are in the locale where the original follicles quit producing hair?

RLB: The cells we are using to address pattern baldness (androgenetic alopecia) are taken from a cell population found at the base of the hair follicle. These DSC cells are used to produce our RCH-01 product. Research has demonstrated that these cells are responsible for the reorganization of the hair follicle, which is a mini-organ that organizes upon an unknown signal. Our research leads us to believe this cell population is responsible for hair regeneration.

We source our particular cells from hair follicles isolated from the back of the scalp, between the ears, because most balding people retain this area of hair. This hair is insensitive to the androgen hormone (DHT), which causes hair loss, making these hair follicles prime candidates for our hair regeneration product.

“We are preparing to launch a very significant Phase 2 trial using our RCH-01 (dermal sheath cup [DSC] cells) for hair regeneration.”

As to the question of whether this will be a durable response—how long the hair will last—this is one of several questions both we and Shiseido are targeting in our respective upcoming pattern baldness trials. We’re designing this next phase to look at dosing. We’re also looking at frequency of treatment: One cohort of the study gets a single treatment, another gets a second treatment at day 91.

But we’ll also be following these patients for a considerable length of time, to see whether the intended effects are maintained or whether they diminish over time. Even though there are only a proposed 160 participants, utilizing different dosing and different injection points throughout the scalp, there will be 396 treatment sites, or data points, that we will be able to gather from those 160 patients, in addition to the data to be gleaned and shared from the trial Shiseido is funding in Japan. These questions are great—effectiveness and duration of effect—and we have an obligation to answer them, which is why the trials are designed the way they are.

TLSR: What else is RepliCel working on at the moment?

RLB: We have another population of cells derived from the hair follicle (the non-bulbar dermal sheath cells [NBDS cells]) that we believe is a platform capable of generating multiple products for various indications. These cells can be readily expanded, and it turns out they are highly expressive of type 1 collagen. Our first trial with these cells will be using our RCT-01 product for the treatment of chronic Achilles tendinosis.

Up to 90% of healthy tendon is comprised of well-constructed type 1 collagen, and a number of indications manifest in patients due to the loss of type 1 collagen production in the endogenous cells, one of which is Achilles tendinosis. Tendons often are not well vascularized, and after a series of injuries and as a patient ages, the endogenous fibroblasts are exhausted of their ability to continue to produce the type 1 collagen necessary to support healthy tendons. RepliCel’s predicate science is built around the injection of autologous (harvested and administered back to the same patient) fibroblasts capable of producing the kind of collagen needed to restore the patient to healthier function and better pain scores.

TLSR: Do you have evidence of actual tendon regeneration?

RLB: In three tendinosis-related clinical trials performed using a similar cell type, which has now been licensed into the company, MRI imaging shows that tendon treated with this cell type was much more akin to healthy, young, functioning tendon than what the patients had prior to injection of cells. This is an exciting platform, and the company is about to launch a Phase 1/2 trial in chronic Achilles tendinosis. We believe the cells could also have application in other indications, including jumper’s knee, golfer’s elbow, tennis elbow and torn rotator cuffs, as well as in a number of dermatological applications. Late this year, we will launch a Phase 1 study in healthy volunteers to look at the ability to regenerate the underlying tissue of skin in patients who have aging or sun-damaged skin.

TLSR: Achilles tendinosis and androgenic alopecia are very different indications. Androgenic alopecia is a hormone-dependent condition, while Achilles tendinosis is trauma-related.

RLB: That’s a great point. Even though both of these studies—tendon repair and hair regeneration—use cells derived from the hair follicle, we’re working with two very different cell populations. As a result, they have the ability to elicit very different, targeted responses.

TLSR: RepliCel’s shares have suffered considerably over the past six months. What caused the dip and what is the company doing to fix the issue?

RLB: The fact of the matter is the company was delayed in progressing to its Phase 2 trial for RCH-01 in hair regeneration because of an issue with the supply of a critical growth media. The new media wasn’t producing the same results, so we had to go back to the drawing board and discover what the problem was. The comparability data is now coming in to support our belief that we’ve solved that problem. We have four trials expected to launch in the next few months (three of ours and one of Shiseido’s). Two of these are expected to give clinical readouts late next year. Until we are a company executing clinical trials, we are a company talking about executing clinical trials, and certain investors grow understandably impatient.

“We have another population of cells derived from the hair follicle that we believe is a platform capable of generating multiple products for various indications.”

I’m very pleased that in October we submitted an application to Health Canada for the proposed Phase 1/2 clinical trial for chronic Achilles tendinosis. This triggers a 30-day window during which Health Canada can provide a No Objection Letter allowing us to proceed with the trial. This event is the initial trigger for a cascade of catalysts anticipated over the following months related to this trial, as well as our proposed Phase 1 clinical trial in Germany for aging and sun-damaged skin, our proposed Phase 2 trial for pattern baldness (androgenetic alopecia) in Germany, and Shiseido’s upcoming trial for pattern baldness in Japan. We’ve been on the road for several weeks, crisscrossing the U.S., Canada and Japan, talking to investors, analysts and potential partners. We are pleased with the level of interest being generated, and believe that once we demonstrate we are executing on schedule, we will generate increased support.

TLSR: Is it possible that all these milestones will be met by the end of 2014?

RLB: We are working very hard to make that happen. I believe we’re on target to have our three clinical trial application filings submitted by year-end. We expect Shiseido to file its clinical trial application early in Q1/15.

We are, of course, dependent on regulatory clearance to initiate any trial, but we have had very active dialogues with the regulators overseeing all our proposed trials, and are submitting precisely what has been discussed. As mentioned, we have now filed the first of our three applications. The second trial application proposes to use a product (RCS-01) developed from the same platform technology, so the clinical-regulatory team can leverage much of the work already done to get the second application filed.

One thing to note is that the dermatology and tendinosis trials are relatively quick studies to enroll. We’ve been in constant dialogue with the principal investigators of the RCT-01 trial in chronic Achilles tendinosis, and they assure us there’s a pipeline of patients waiting to enroll in the study. The RCT-01 tendon trial is going to be a 28-participant study, and the RCS-01 in skin rejuvenation is a proposed 28-participant study design as well, but using healthy volunteers. The RCH-01 hair regeneration study is going to extend over a longer period of time, because it targets 160 participants. But the RCT-01 and RCS-01 studies will be relatively quick to enroll and to follow up on, and we expect data in 2015 for both of those.

Both of these studies are randomized, placebo-controlled and specifically designed to provide measurable and material biologic and mechanistic data that we will use to drive partner discussions. Remember that the company’s business model is to codevelop assets with partners who understand the markets and have proven commercialization capabilities.

We are excited about being in the position we are now in, poised to imminently execute on three clinical trials, finalize the development and validation of our propriety injection device (which has licensable applications for acellular injectables), capitalize on our partnership with Shiseido and the innovative regulatory pathway for regenerative medicines in Japan, which provides a window to early-market access for our pattern baldness treatment, and to execute on one or more additional licenses with codevelopment partners in the near term.

TLSR: Thank you very much for your insight, Lee.

RLB: Thank you.

R. Lee Buckler is vice president of business and corporate development with RepliCel Life Sciences Inc. Prior to working with RepliCel, he was the managing director of Cell Therapy Group, a firm he formed in 2008, where he did business development consulting for companies and organizations in or interested in the cell therapy sector. Buckler served six years as executive director of the International Society for Cellular Therapy, and just over two years as director of business development for Progenitor Cell Therapy. He is on the editorial advisory boards of the journal Regenerative Medicine and the BioProcess International magazine, as well as the co-chair of the Alliance for Regenerative Medicine’s Communications and Education Committee. Buckler cofounded Cell Therapy News, founded Cell Therapy Blog, cofounded Regenerative Medicine Jobs, founded and continues to manage the LinkedIn Cell Therapy Industry Group, and is an active industry commentator in publications and in social media. He serves on numerous industry conference advisory boards, is an advisory board member for BioCision and RoosterBio, and is on the board of directors for Hemostemix. He has a bachelor’s degree in education and a law degree.

Want to read more Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you’ll learn when new articles have been published. To see recent interviews with industry analysts and commentators, visit our Streetwise Interviews page.

DISCLOSURE: 1) George S. Mack conducted this interview for Streetwise Reports LLC, publisher of The Gold Report, The Energy Report, The Life Sciences Report and The Mining Report, and provides services to Streetwise Reports as an independent contractor. He owns, or his family owns, shares of the company mentioned in this interview: None. 2) RepliCel Life Sciences Inc. paid Streetwise Reports to conduct, produce and distribute the interview 3) R. Lee Buckler had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of R. Lee Buckler and not of Streetwise Reports or its officers. 4) The interview does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. 5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their families are prohibited from making purchases and/or sales of those securities in the open market or otherwise during the up-to-four-week interval from the time of the interview until after it publishes.

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To listen to the full interview podcast and read the transcript click here: Midas Letter Interviews David Hall

Full Transcript:

James West: Let’s start off with an overview of exactly what the value proposition is for investors in RepliCel?

David Hall: RepliCel Life Sciences is an autologous cell therapy company that is developing treatments for aging and sun-damaged skin, chronic tendinosis…so any kind of tendon injury that people can imagine, and pattern baldness for males and females. I suppose the near-term catalytic investment proposition is that we’re within days of filing a clinical trial for chronic tendinosis in Canada, and that will be followed in a few weeks with a filing for a clinical trial in Europe for aging and sun-damaged skin, and then later on this year we’ll get into our Phase II trial for pattern baldness. So a lot of things happening.

James West: Yeah. That’s quite a broad mix of applications for one product. What is the essential technology? What is it all centered around?

David Hall: The technology comes from isolating specific cells from the human hair follicle. In the case of treating chronic tendinosis or sun-damaged skin, it all relates to a cell called a fibroblast, which we isolate from the sheath of a hair follicle, and these particular fibroblasts – which can also be isolated from other parts of the body – these particular fibroblasts are particularly proficient at producing type I collagen, which is the major substance structure of a tendon – it’s about 90% of the tendon – and of the skin itself. So in the case of a tendon, we’re healing that chronic wound, in the case of sun-damaged skin, we’re actually re-establishing the volume of fibroblasts in the dermis that produce the required proteins and type I collagen to give skin texture. So kind of like turning the clock back, if you will, for our aging and sun-damaged skin program.

James West: Interesting. Okay so how does RepliCel monetize this technology?

David Hall: It’s very straight forward. The company is designed to produce data on safety and efficacy, and take that data and go out and partner it. It is a platform technology where we can take our cells into other indications. Really if you demonstrate safety and efficacy in one fibroblast indication, for example, you’ll be able to take it into a bunch of other things like all of the different tendons, all of the different skin issues including scarring and acne, and burns and all sorts of issues with the skin, as well as things like periodontal disease which is a growing concern for health populations and health payers these days. And of course in terms of pattern baldness, we’ve already monetized it in the sense that we’ve licensed to Shiseido Corporation for Japan and Southeast Asia our cell treatment for pattern baldness, and they themselves are starting their own clinical trials in the not-to-distant future, so there’ll be two clinical trials developing dosing and frequency for that treatment. And once you get that kind of data, you can turn around and sell it for up-front payments for ongoing royalty payments, various sales milestones payments – so there’s lots of ways to monetize it. What we’re not doing is going out and building big factories and trying to build sales forces ourselves. The greatest value for the shareholder is actually to license this technology out at that sort of Phase II data point, of which we’ll get two sets of data next year that will be in that area.

James West: Okay so are you – is there substantial revenue at this point?

David Hall: Ah, no it’s a capital consumer like most biotech’s, although we did take a $4 million up-front payment from Shiseido, but that’s the nature of this game. You consume capital to a certain point in time, and then you produce data that says, well, this is now worth $100 million, $200 million, $300 million, $400 million – those are the kinds of metrics that you get in a biotech company. We know that for example on the derm side of the world, there’s already been one program approved for a company called Fibrocell (NASDAQ:FCSC) with respect to the smile lines in the face. So we know we can get approved through the FDA – that’s not a problem. And we think we have a much more prolific cell in terms of the fibroblast that we’re using. There are partnerships – lots of partnerships – that are coming into the regenerative medicine space. There’s market cap companies like Mesoblast Ltd. (ASX:MSB) (OTCMKTS:MBLTY) that’s over $1 billion, so there’s a vast array of market caps, but all of those examples as you get larger, all relate to delivering data, getting into clinics where there’s anticipation of data. It’s not unlike the junior oil and gas business, or a mining property, where there’s drilling, and you get that early evidence of an asset, and then you have to drill it out, and so we’re in the process of drilling it out, because we have that early asset. That’s probably a good analogy.

James West: Mm-hmm. Okay so let’s talk about that a bit. So analogous to what major market cap companies did you say that RepliCel is similar to?

David Hall: As I said, Fibrocell has a market cap around $100 million. They have a fibroblast treatment for the face – that’s one of our indications that we think we can improve on. There’s companies like Mesoblast Limited (ASX:MSB; USOTC:MBLTY) that are over $1 billion and they’re much more sophisticated – well not necessarily more sophisticated – they’re using bone marrow derived mesenchymal stem cells. We’re actually just using a target cell and we’re just making more of them. So we have a lower safety hurdle, but that’s an example of a company that is a leading one. And then there’s, other companies in between, like the Israeli company called Pluristem Therapeutics Inc. (NASDAQ:PSTI) – Nasdaq-listed, $200 million market cap, and they’re basically using placenta-derived stem cells. What we’re doing in contrast to all these other companies, is just simply taking a specific cell from the patient, and making more of them, and then moving them into the area where they’re required. So in the case of tendinosis, there’s a lack of these fibroblasts, and we can isolate really prolific fibroblasts, and replicate them and stick them directly into the wound.

The same concept as with the skin, or with a burn or with scarring acne. And with the case of pattern baldness, there is a specific cell that is missing in those people who are affected by androgen – it’s called a ‘dermal sheath cup cell’. We take androgen insensitive dermal sheath cup cells from the back of the head, replicate them and then inject them into the top to replenish a population of unhealthy dermal sheath cup cells to rejuvenate the hair follicle that’s been losing the thickness and the size of the fiber growth that comes from that hair follicle. So it’s really elegantly simple science, and it’s just a matter of us executing now, and that’s what we’re doing. We’re going into two clinical trials, our Japanese partner will start one later this year, so a lot of activity.

James West: Okay so let’s focus for a moment on the pattern baldness concept. I mean I would just think that if you came up with a cure, I mean a real cure, for pattern baldness that you would have yourself a very valuable company on your hands. Now has your strategy or your approach to pattern baldness been tested on human beings at this point?

David Hall:Yes. We actually did a 16 patient Phase 1 study, which is the basis of the data that we’re using for our Phase 2 study, as well as the data that’s being used by Shiseido Company in Japan to file for their trials. So in that safety trial that was 16 patients – only 16 data points – we had an average density growth in 6 months, which is all the trial went for in terms of the safety measurements – of 11.8%. Now, by contrast, the very best you get with the current drug therapies of Minoxidil or Rogaine – is about 16% and Finisteride, which is for Alapecia, is only about 14%. And those are over 12 months. So we know that we’re going in the right direction in terms of the density, and indeed about 70% of the responders were above 10%. And they averaged around almost 15%.

So we know we’re going in the right direction, and that was only with 16 patients. Now, the next step for us, is a 160-patient trial that will measure frequency and dosage. We need to determine if you have to give more than one injection to get a serial conversion of healthy hair follicles? And the other aspect is determining the best dosage so we will be testing three different doses. And that’s going to give us 390 data points versus the 16 that we had before, so we know we’ll have far greater data that will tell us what is the dose and what is the frequency, in order to treat somebody and get their hair follicles basically converted over to a population of androgen-insensitive cells. And androgen is the problem. No one knows why, but in some people androgen causes pattern baldness, and in some cases androgen causes people to have undesirable growth on different parts of their body. You know, it’s just how humans are. But we do know that the cells at the back of the head are completely androgen insensitive, and if you take those cells, replicate them, and put them up into the area of the pattern baldness, the goal is to let that population recruite into every hair follicle fiber cycle, and basically rejuvenate the population of cells that have been previously compromised by androgen. Again, very simple concept – now we just have to execute and figure out what dose, and what frequency.

James West: Yeah okay so is it looking to you like a complete cure? I mean so is a guy who’s bald as a cue ball going to be able to grow hair down to his butt? Is that what we’re talking about here?

David Hall: Yeah I mean that’s the point…based on the 16 patients that we tested, we were able to do a $35 million deal with Shiseido Corporation; $4 million up front, and $31 million in milestones and then ongoing royalties for Japan alone, and South Asia. So we really attracted a big company – they are the fourth biggest cosmetic company in the world – to the elegance of the science. And the outcome is yes – to simply change the outcome of pattern baldness. So if you think of yourself…the back of your head has hair follicles that produce fiber. The problem is that on the top of the head, over the years, your hair follicles, the cells called dermal sheath cups at the bottom of those hair follicles in the top of your head – they have been compromised by androgen. But the back of your head has hair follicles that are completely androgen insensitive, so we’re taking those cells – the cells from those follicles, it’s a single maybe two suture punch biopsy, and isolating those androgen-insensitive cells, and making them into millions, and then injecting them back up into the scalp. And every hair fibre cycle that you have causes the cells to turn over, and now we’re integrating these cells that are insensitive to androgen. So if we get the right dose, which is what we’re doing right now, and you have to get the right frequency, in other words do you have to take more than one injection – then the logical conclusion is that you get a complete serial conversion to a healthy hair follicle which you had when you were younger. And that’s kind of the goal. And it makes sense scientifically, but the challenge is you’ve got to figure out the dose and frequency, and that’s just a matter of trying.

James West: So the short answer to the original question then is ‘maybe’. Maybe this is a complete cure?

David Hall: Well if it works, then it’s a cure. I mean you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen. That is the goal, and as I said it’s a matter of dose, and frequency that we’re trying to figure out between ourselves and Shiseido.

James West: Well that’s great…that’s a perfect first interview. We’re going to catch up with you in about another quarter and see how you’re making out. Thank you for joining us today.

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By: Eric Chiu, Biotech, Healthcare Contributor
Published October 10, 2014

To read the entire article as it appears on Seeking Alpha click here.

Summary

RepliCel’s partnership with Shiseido shows validation from a major third-party player and potentially advanced access to revenues.
The results from Phase I trials show compelling data of up to 19.6% increase in hair density for RCH-01.
For a $23M market cap, I believe RepliCel is an under researched firm that possesses a diverse drug pipeline.

RepliCel Life Sciences, Inc. (OTCQB:REPCF) is a company focused on the development of autologous cell therapies currently targeting pattern baldness, tendonosis and aging skin. The technology is based upon two different cell types derived from the hair follicle. One product is comprised of dermal sheath cup cells which are believed to be responsible for generation of hair follicles. The other product is a platform technology comprised of fibroblast cells responsible for the synthesis of Type I collagen. In both instances the cells are derived from a small (single-suture) biopsy taken from the back of a patient’s head.

Hair-derived fibroblast cells such as those under development by RepliCel, have been shown to produce five times more Type I collagen than fibroblast cells derived from skin. RepliCel’s products are administered to the target site in need of repair using a proprietary purpose-designed injector, also under development by RepliCel. This has been optimized for the administration of cell suspensions and other cellular injections.

According to the company, its cell-based products enjoy several beneficial attributes due to their autologous use:

No risk of a patient rejecting the cells, their minimal invasiveness to obtain the starting material (a single-suture biopsy from the back of the head).
Lack of cell manipulation aside from mere replication.
Cost of production capable of supporting commercially attractive margins at a reasonable price point for payers
Employ cell populations purpose-designed for their intended therapeutic effect unlike many of the stem cell therapies in development.

The goal of RepliCel is to generate compelling Phase I and II data for potential licensing or sale to larger life science companies with experience, expertise, and capacity for commercializing product to market. The intent is to de-risk technologies for late-stage partners which delivers nearer-term return on investment to shareholders than would exist for those investing in a company aiming to take a product through commercial approval and distribution.

Deal With Shiseido

In July 2013, RepliCel announced it had completed a collaboration and Technology Development agreement with Shiseido Company Limited, the world’s fourth largest cosmetics firm. This gave Shiseido exclusive market rights for the hair regenerative technology, RCH-01, in the ASEAN countries including, Japan, China, Taiwan and South Korea. The deal included a $4M upfront payment and sales milestones of up to $31.5M plus other sales royalties. Furthermore, the agreement established a joint steering committee to ensure continued research and development of the product was done collaboratively and the results of any such efforts would be shared. Shiseido is expected to launch their own clinical trial of RCH-01 imminently and will share this data with RepliCel for their own use in development and further licensing discussions pertaining to markets outside of Shiseido’s. Recently Shiseido announced they’ve already opened their constructed manufacturing facility to support clinical testing starting later this year.

The implications behind this partnership are huge. For one, Japan has taken initiative to be the global leader in regenerative cell therapies. In 2013 they revised the Pharmaceutical Affairs Law which allows regenerative medicines to be marketed before full authorization by the government. Data from the first consumers will be collected and used in the full market authorization approval.

Figure 1. Diagram of Japanese authorization process with revised Pharmaceutical Affairs Law.

For RepliCel this means:

Potentially faster access to sales royalty and milestone revenues if Shiseido gets the product through conditional approval in Japan

More clinical data points since Shiseido is funding their own trial

Validation from a major life science firm, that has done extensive due diligence on the hair regenerative market, company and technology

Current Research Data and Forthcoming Trials

Figure 2. RepliCel’s product pipeline and current development phase.

Hair

RepliCel’s Phase I trial of RCT-01 for treatment of pattern baldness resulted in firmly establishing the product’s safety. The study designed for safety, met its endpoint with no reported adverse side effects aside from a temporary, mild burning sensation at the injection site reported by some patients.

Efficacy was only measured up to the six-month point even though efficacy doesn’t typically peak until the 12-month post-treatment for other products or treatments. At six months, 63% of the “responders” (patients achieving over 5% density increase) experienced an average density increase of 11.8%.

Figure 3. RCH-01 Phase I results at the six-month mark.

Current Treatments for Hair Loss

The gold standard for hair loss treatment is micro-transplant surgery, which is a costly and extremely time consuming treatment. This would be for patients that are looking for dramatic change and have the means to do so. Rogaine is a topical solution available for men and women that increase hair density by 8%-16% at the 12-month mark, which needs to constantly reapplied. Propecia is an oral pill, for men only, that increases hair density by 7%-14% at the 12-month mark, which again needs to constantly be reapplied.

While the results were varied, a single injection of RCH-01 saw results, at the six-month mark, of up to 19.6% increase in hair density in a sample size of 16 people. Overall these are very impressive results and it was this data package that compelled Shiseido to seek out a deal for the technology. RepliCel’s pending Phase II trial of RCH-01 will study single vs. double injections and also investigate different doses.

RCH-01 fits into the market between surgery and drugs offering potentially stronger results through the means of a less invasive clinical treatment. This would be between the micro-transplant surgy which is expensive, and the drugs Propecia and Rogaine, which carry the risk of side effects and must be consistently reapplied for effectiveness.

Things to look for in the Phase two trials will be the percent change from baseline and the effectiveness of increased dosage and/or multiple injections). Even in the event that RCH-01 does not show a significant increase in both effectiveness and responders, RCH-01 can position itself in two ways for consumers; if the number of responders is increased, this can be potentially used as a combination treatment with hair regenerative drugs. Secondly, if the percent change from baseline shows a dramatic increase in a limited set of responders, it would be worth a clinical visit even if response percentages are low. In such case, it may justify doing a subset analysis or other preclinical work to identify patient biomarkers capable of predicting responders.

The upcoming trial will initiate in late 2014 or early 2015 costing $2-$2.5M over two years with data expected to be released in 2016.

Tendonosis

A study by Dr. David Connell showed significant changes in pain and function scores in patients with Achilles tendinosis through the introduction of dermal fibroblast cells. It has been shown that these cells are not as strong as fibroblast cells from the dermal sheath (RepliCel’s technology) at synthesizing Type I collagen. As a result, Connell licensed his intellectual property, data, and technology to RepliCel and joined as an advisor.

RepliCel’s anticipate Phase I/II study, titled “A randomized, double-blind, multi-centre dose-finding study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis,” addresses the inherent deficit of active fibroblasts required to regenerate healthy functioning tendon after injury. The trial, to be conducted at the University of British Columbia (Canada), will measure several safety and efficacy endpoints following a single injection of RCT-01. The study will be performed over 12 months costing under $1M and will initiate later this year. Six-month efficacy data is expected in second half of 2015.

Chronic Achilles tendinosis is a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury resulting in ongoing pain and loss of function. Healthy functioning tendon is comprised of highly structured Type 1 collagen which resident fibroblasts play a significant role in producing and maintaining. RCT-01 is a fibroblast platform using cells derived from the patient’s hair follicle. These particular fibroblasts are highly expressive of Type 1 collagen, which is needed to support the regeneration of tendon for patients suffering from chronic tendinosis.

A recent study published in the British Journal of Sports Medicine estimated the incidence rates of Achilles tendinopathy to be .235% of the general adult population (21-60 years). If applied to the U.S. population this would translate into approximately 750,000 people in the U.S. suffering from this chronic condition at any given time.

Skin

Younger healthy skin is typically found to have high density of Type I collagen which decreases as time progresses and UV damage sets in. In a Phase I study of healthy volunteers RepliCel’s fibroblast technology (RCS-01) will be tested for its potential to reverse this and treat the appearance of aged skin. The primary end point will be safety but biopsies will be taken at various follow-up intervals to measure (by histology and FACS analysis) the product’s effectiveness on a number of biomarkers associated with aging skin. This Phase I study will enroll 28 patients costing approximately $500,000 with data available in 2015.

Financials

The company’s cash position as of Q2 results was $4.3M in cash and equivalents. Sporting a current burn rate of $350,000/month which is expected to increase late 2014/early 2015 as clinical trials ramp up, RepliCel will likely be looking at raising cash in 2015. In addition to equity financing the company reports actively exploring funding from other potential partnerships, warrants in the money and other sources of non-dilutive funding. Current shares outstanding of 54.9M and 67.4M fully diluted may raise concerns as returns are dispersed through a large volume of shares. Ownership is 43.5% by founders, officers and insiders, which indicate belief in the product that can be developed and licensed out.

Comparables

Risks

With all micro-cap stocks, especially biotechs, one should be wary of the risks. The valuation of the company is currently based on its potential future returns that carry the uncertainty of being unrealized due to failed clinical trials. RepliCel currently does not generate revenue from operations and faces significant business failure risk. Due to the nature of the product, the success of RepliCel post-approval will rely on the acceptance from the medical community and general public, which may be a hurdle.

Conclusion

This is a company with one Phase I trial, one Phase I/II trial, one Phase II trial, and late-stage prototype development of a new injectable device for $23M market cap. On top of this, there is support from Shiseido, which is funding an additional Phase II trial that could lead to conditional market approval in Japan. That, in turn, would trigger early access to revenue streams for RepliCel. I believe RepliCel is a heavily under-researched stock that has a lot of potential to be a disruptive player in the regenerative medicine sector.

Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

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VANCOUVER, BC – October 2, 2014 – RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), clinical stage regenerative medicine company focused on the development of autologous cell therapies will be presenting at the Stem Cell Meeting on the Mesa Partnering Forum on Tuesday, October 7, 2014 at 11:45 a.m. local time in La Jolla Ballroom 2 at the Estancia La Jolla Hotel.

The presentation by Mr. David Hall, CEO, will include an update on RepliCel’s pending clinical trials for chronic Achilles tendinosis (RCT-A-01) and sun-damaged and aging skin (RCS-01) as well as its program for pattern hair loss (RCH-01). It will be webcast and posted on the conference website at http://stemcellmeetingonthemesa.com/webcast/, on RepliCel’s website at http://www.replicel.com/investors/corporate-publications/ and on the Alliance for Regenerative Medicine website, after the event, at http://alliancerm.org/ bringing tremendous exposure to the company.

“The Stem Cell meeting does an excellent job of bring together leading researchers, clinical experts, senior executives, health care investors and top decision-makers in the regenerative medicine industry. With nearly 800 attendees from around the globe, it is a great environment for discussions around partnerships, collaborations and investment,” commented David Hall, CEO of RepliCel.

Please visit http://stemcellmeetingonthemesa.com/ for full information on the conference including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function. The company’s RCT-01, RCS-01 and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aging skin, and pattern baldness. Shiseido Company, Limited has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles. The company is also developing a propriety injection device optimized for the administration of its products and licensable for use with other dermatology applications. The company’s product pipeline is comprised of multiple clinical trials all anticipated to launch in late 2014 in addition to Shiseido’s own clinical trial of RCH-01 and the device in late prototype development. Visit www.replicel.com for additional information.

For more information please contact:

Tammey George, Director of Communications
Telephone: 604-248-8696
tg@replicel.com
www.replicel.com

INVESTOR RELATIONS:
Christina Cameron, Investor Relations
christina@clcameron.com

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The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.

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