Media

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To read the article on The Life Sciences Report, click here:

It makes no sense to look at stem cell companies differently from drug or biologics companies. The technology may be different, but the diseases they seek to treat are the same. In fact, cell therapies may ultimately be more useful and more curative than drugs, and hence more valuable. That’s the way Alain Vertès of NxR Biotechnologies sees it. In this interview with The Life Sciences Report, Vertès talks about some of the stem cell names he knows well, and draws comparisons investors can bank on.

The Life Sciences Report: Alain, you have compared the current stage in the development of the stem cell and regenerative medicine industry to the beginning of the monoclonal antibody revolution. Companies formed to leverage stem cell technology have been around now for three decades. When are we going to start to see the approval, marketing and reimbursement of some of these technologies?

Alain Vertès: I am quite optimistic we’ll see these things soon, I have to say.

It’s true that there is a very nice parallel between the technology of stem cell therapeutics and the technology of monoclonals. A historic look at monoclonals is a very insightful way to understand the stem cell industry, in the sense that it took about 25 years for monoclonal antibodies to emerge as a mainstream product category. As recently as 2007, there were only a handful of companies with double-digit sales derived from monoclonal antibody-based therapies. The transition and penetration of this new technology class started quite slowly. I think we are witnessing something similar with stem cells and regenerative medicine.

“Athersys Inc.’s MultiStem could very well be among the first few products approved in Japan.“

Considering only mesenchymal stem cells, I would say that by 2017 we should have good clarity regarding deployment in major markets. First of all, we have Prochymal (allogeneic human mesenchymal stem cells; [remestemcel-L]), a product developed by Osiris Therapeutics Inc. (OSIR:NASDAQ) and acquired by Mesoblast Ltd. (MSB:ASE; MBLTY:OTCPK) in October 2013. Mesoblast is continuing the development of Prochymal in refractory Crohn’s disease. It has been conditionally approved in 2012 in Canada and New Zealand for the treatment of acute graft-versus-host disease in steroid-refractory pediatric patients, and should be deployed in major markets relatively soon, including in Japan, where it is developed by Mesoblast’s partner there. I think Prochymal, for this particular indication and for this particular patient population, will be one of the first stem cell therapies to hit the market. Having said that, let’s not forget that South Korea has already approved some of these therapies.

It is interesting also to look more closely at what is happening in Japan. That country has a new law that essentially enables companies to more quickly develop and deploy stem cell technologies into the market, as long as safety is demonstrated. This is particularly in response to an aging society, and the observation that conventional pharmaceutical approaches have not satisfactorily addressed a range of indications—for example, stroke as a leading cause of death and disability—that impose high social and financial burdens. Regenerative medicine products could change this. The Japanese parliament enacted the new law in November 2013, revising the Pharmaceutical Affairs law to define new regenerative medicine products. Companies can now get conditional approval for stem cell products after they show safety, like they would in a Phase 2 trial.

“Right now, RepliCel Life Sciences Inc. is positioned with very good potential.”

On March 2, Chugai Pharmaceutical Co. Ltd. (4519:TSE) and Athersys Inc. (ATHX:NASDAQ) announced a deal using Athersys’ MultiStem (allogeneic multipotent adult progenitor cells) product for the treatment of ischemic stroke. MultiStem could very well be among the first few products approved in Japan. But then again, the law will be beneficial for all stem cell companies, which is very exciting.

TLSR: We are just starting to see oligonucleotides come to the market as approved therapies. It appears to take a quarter of a century for a new technology to move from lab bench to treating patients. Would you agree?

AV: It does appear that way. Hopefully, with the accelerated pathway we’re seeing in Japan, novel therapeutics will take a lot less time to get to patients. And even outside Japan, given the number of trials in Phase 2 and Phase 3 that will be reading out this year or next year, we should see some cell therapy products begin to emerge.

TLSR: Unlike cell technologies, the monoclonal antibody industry is relatively straightforward. Monoclonal antibodies act pretty much the same way as small molecules do: They engage or inhibit a protein on a cell membrane to alter signal transduction into and within the cell. With stem cells, aren’t we talking about a much more complex system? Cells perform most all metabolic activities, including reproduction. Importantly, they also express multiple genes. Are we talking about apples and oranges here?

AV: I think we can have both perspectives. We can say that stem cells and monoclonals are very much similar in terms of the S-curve of development. Speaking retrospectively, it’s quite easy to identify the S-curve that made monoclonal antibody products a reality. When we started with murine (mouse) antibodies, those didn’t work because of immune reactions. We had to progress upward on the S-curve from murine to chimeric (combining genetic elements from nonhuman and human) to humanized, and to fully human antibodies. When we reached the last level, the technology became mature enough to penetrate the market. It was only a question of allowing innovation to take over. If we look at stem cells, we see very similar lower stages of S-curve development. The safety of mesenchymal stem cells is now clear. It’s a little bit less clear for induced pluripotent stem cells or embryonic stem cell products.

“The market is still not valuing stem cell programs and companies fairly; this is a very exciting time for proposed stem cell therapies.”

But there is a difference. For the first time, we have pharmaceutical-like products—these cells—that are able to be implanted and enrich a target microenvironment. Cell therapies represent a critical development in healthcare because we now have a therapy that is going to understand, for lack of a better term—or rather sense, through a complex network of signal transduction relay molecules—the specifics of the microenvironment it encounters when it is implanted or infused. These cells will then respond as well as possible based on the area of the body targeted and, of course, based on the specific disease. We thus have the machinery to develop a fresh salvo and create arrays of cytokine growth factors and beneficial effects. That’s what makes cells better at targeting disease.

TLSR: I know you have some thoughts about the failed Athersys/Pfizer Inc. (PFE:NYSE) Phase 2 trial with MultiStem, which was reported at the end of April 2014. This study, randomized and double-blind with 126 patients, failed to meet its primary endpoint of reducing the incidence and severity of adverse events in ulcerative colitis. Did that have a chilling effect on big pharma companies, which saw Pfizer fail in this trial?

AV: I don’t think it scared companies away because, regarding stem cell therapies, big pharma is really in the monitoring mode at the moment. Everybody in large pharma understands that emerging technologies will lead to some failures, so that’s not a surprise. Going back to monoclonal antibodies, the first 15 clinical trials were failures. That’s important to keep in mind, because emerging technologies are very challenging.

“Hopefully, with the accelerated pathway we’re seeing in Japan, novel therapeutics will take a lot less time to get to patients.”

I don’t think the Athersys/Pfizer failure was a dramatic problem. Understand that if we look at the fundamentals and properties of Athersys’ cell technology, they are still rock solid. Looking at the details of that Phase 2 trial with MultiStem, Athersys and Pfizer set a very, very high bar for success in terms of trial design. One reason this was so challenging was that they were essentially attempting to treat patients who were very sick, and who had already failed several types of therapy. I don’t think this was a major failure for the field of stem cell technology. It’s clearly a setback, but it’s not a fundamentally worrying setback. I don’t think it scared away people.

TLSR: You said the bar was set very high. Do you think the single-infusion design was a problem? That single infusion of cells was intended to treat or alleviate a disease some patients had been suffering with for a decade, and in some cases for half their lives. I don’t think a small molecule or even an antibody would be expected to work with a single administration.

AV: That definitely was the case. These patients had chronic moderate to severe disease for an average of ten years, and a single injection may not have been sufficient. Also, maybe the company would need to treat patients earlier in their disease progression. It was a very high bar.

TLSR: Athersys’ share price has more than doubled over the last three months. My understanding is that short covering was a contributor to that share-price appreciation, but it’s clearly a good sign. Would you summarize your thoughts on Athersys?

AV: The stock price has been recovering from the trial failure. As far as MultiStem goes, it has been found to be safe. I do like this company, and its prospects are quite positive.

TLSR: Can you speak to another company working in the cell therapy space?

AV: Yes. I’ve looked at RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB), and I think it’s an interesting company, especially when considering its business model. It has an autologous cell therapy model for hair transplant and Achilles tendinosis. In addition, the company has developed a very clever way to deliver its autologous cells for both of its indications—a dermal injector device. Its business model offers investors a reasonable cost of goods sold (COGS). RepliCel has also established a strategic partnership with Shiseido Company Ltd. (4911:TSE) in Japan. This is a partnership with a very good company. Right now, RepliCel is positioned with very good potential. I do not see any fundamental flaw or problem with this company.

TLSR: It has been a rough year for stem cell companies in general. Many companies working in the space have seen double-digit declines in their stock prices. But there’s one company that stands out because of its valuation. Mesoblast had more than a $2 billion ($2B) market cap two years ago. Now it’s just $1B. What is going on with Mesoblast?

AV: There has definitely been a group effect with regard to the share prices of all these companies. But the case of Mesoblast is very interesting. The company was at the height of its valuation a couple of years ago, and there was a correction in the stock price, following these systemic trends that you just mentioned. The key question here is whether there is a major, fundamental issue in the company.

The answer is no. There is no flaw in terms of the company’s fundamental technology; that technology is rock solid. In terms of practical application, the company is solid as well. If we look at the portfolio of Mesoblast indications, there are several disease areas. The company has immunology, oncology, orthopedics and cardiovascular, and in each one of these indications—all of which are major—you have Phase 2 and Phase 3 programs in progress. The essential question we have to ask is, “What is the real valuation for a company with a portfolio like this?” If we were talking about monoclonal antibodies, the valuation of this company would be significantly more than $10B. If we were looking at comparable pharmas, it would be even bigger.

What I’m trying to say is that the market is still not valuing stem cell programs and companies fairly. I think this is a very exciting time for proposed stem cell therapies. If you look at companies with products on the market for similar disease indications, and compare those valuations to the low valuations of stem cell companies, you can see real value here.

TLSR: Alain, it was a pleasure meeting you.

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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.

New Treatment for NFL Players and Pro Athletes Offers New Hope

Story by: Jo-Carolyn

New York, NY, January 26, 2014 – Reversing career-ending injuries like chronic tendinosis, a common medical condition caused by a cycle of incomplete healing and re-injury that leads to a painful degenerative state, is the focus for RepliCel Life Sciences Inc., a clinical stage regenerative medicine company. Tendinosis is often caused by sports related injuries, occupational overuse, aging and poor general health. Chronic Achilles tendinosis can affect both physically active and inactive individuals, accounting for 30 to 50% of all sports injuries and 50% of occupation-related disorders in the United States.

Replicel is proud to announce they recently received a No Objection Letter from Health Canada that will allow them to proceed with a clinical trial investigating the use of RCT-01 to treat patients suffering from chronic Achilles tendinosis. “The trial will include 28 patients who have this condition and have undergone physiotherapy with no improvement. We will be giving them a single injection, directly into the Achilles tendon using ultrasound guided imaging, of replicated collagen producing fibroblast cells isolated from the dermal sheath of their own hair follicles,” said CEO David Hall.

The injected fibroblasts should promote the healing process by producing proteins that are necessary for restoring tissue’s structural integrity as well as type I collagen fibers which orientate themselves along the direction of the stretch of the tendon. “The anticipated long-term outcome is the return of normal tendon structure, improved function and zero pain,” adds Hall.

“Health Canada’s No Objection Letter for RepliCel’s ReaCT trial within 30 days of the Company’s first clinical trial application not only supports the technology, but evidences the great work done by the clinical team in terms of the trial design,” commented Dr. Ross Davidson, Chair of RepliCel’s RCT-01 Clinical Advisory Board and retired Clinical Professor, Department of Orthopaedics, UBC. Adding, “I expect this trial focused on chronic Achilles tendinosis to be the first step in addressing other debilitating tendon injuries in the future.”

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. They appointed respected leaders in the field of treating tendinopathies to support the clinical development of its RCT-01 autologous cell therapy. Their newest Clinical Advisory Board Member is Jack E. Taunton, M.D. A visionary and leader in the field of sport medicine, Taunton is a Professor in the Faculty of Medicine, Division of Sports Medicine at the University of British Columbia and has a clinical practice in sports medicine. He served as Chief Medical Officer at Vancouver’s 2010 Winter Games. A marathon runner himself, Taunton became interested in medicine after surviving polio as a child and a severe car crash as a teen.

An approach using autologous cell therapy has never been tried before but Hall and Taunton are eagerly looking forward to results from the clinical trials. RepliCel successfully pioneered regenerative cell therapy as a non-invasive cure for hair loss; that work launched this innovative treatment. To learn more about the study please visit www.tendonstudy.com, or for information on regenerative cell therapy for tendons, please visit: http://www.replicel.com/product-pipeline/rct-01-tendon-repair/.

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To listen to the full interview, click here or view the file below.

CEO & President Mr. Hall was interviewed on ESPN New York Radio – the Worldwide Leader in Sports News, discussing how RepliCel’s cell therapy treatment could help professional athletes resolve their chronic tendon injuries.

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Written By: James West

Listen to the full interview here.

RepliCel’s VP Lee Buckler explains the excitement among company stakeholders surrounding upcoming trials of RepliCel’s autologous cell therapy approach to chronic Achilles tendinosis, and other catalysts in 2015. RepliCel received Health Canada approval for the clinical trial to go forward on December 1st, 2014.

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Using Your Own Cells to Heal Tendon Injuries

RepliCel is developing an autologous cell-based product for the treatment of chronic Achilles tendinosis. This treatment has the potential to restore a patient’s chronic tendinosis to a completely healed state. To learn more watch our two minute video.

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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.

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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To read the full report click here: R. Lee Buckler on the Cell Therapy Industry

Last year, Japan rolled out the red carpet for cell therapy developers with new legislation designed to expedite development of regenerative medicine solutions for all manner of disease. In this interview with The Life Sciences Report, former regenerative medicine consultant R. Lee Buckler, now a vice president with RepliCel Life Sciences Inc., puts his consultant’s hat back on to talk about Japan’s hospitable stance on proposed cell therapies. He provides an update on the meaning of the new law and discusses a small cohort of companies poised to reap the advantages.

The Life Sciences Report: Lee, you’ve been around the stem cell and regenerative medicine industry for quite a long time, and you have a special interest in the new legislation enacted by the Japanese Diet (parliament) back in November 2013. The intention of the law is to hasten clinical development of cell therapies and regenerative medicine therapies. A new cell therapy can get conditional approval in Japan for a limited time with clinical (Phase 2) data showing safety in humans. This new law goes into effect in November. Tell me your thoughts.

R. Lee Buckler: The entire industry is watching Japan and this new regulatory model with an incredible amount of interest. We’re on the brink of seeing more detail around the regulations.

“Athersys Inc. is putting boots on the ground in Japan to develop a strategy there.“

This initiative sets up a paradigm of conditional approval, where a company can bring an application to the Japanese regulators, and if it shows sufficient safety evidence and some evidence of efficacy, the company could get conditional approval to sell its product in the Japanese marketplace. This conditional approval would be for a seven-year window, during which the sponsor or sponsors would have an obligation to continue to file clinical data toward an eventual final market approval—a biologics license application (BLA) or the Japanese equivalent thereof. There is also some suggestion that during the seven-year window, some reimbursement will be attached to the product being sold on the market.

TLSR: In mid-September, Pluristem Therapeutics Inc. (PSTI:NASDAQ), an Israeli company, said it was going to pursue a development strategy in Japan. It hired consultants to help the company get into that market. The company’s lead indications are peripheral artery disease, intermittent claudication, critical limb ischemia and muscle injury. But otherwise, I don’t see a lot of other companies initiating programs in Japan. Do you see companies from the U.S., Canada or Europe getting into that regulatory environment?

RLB: I think most companies in the regenerative medicine industry have a tremendous desire to have a Japanese strategy right now. The problem is that a lot of companies in this sector don’t have enough bandwidth, or capital, to execute on that.

However, a few are making Japan a high priority. Currently, less than a handful of companies have a clearly articulated Japanese strategy, and only that many again have begun executing on the opportunity.

“Mesoblast Ltd. is potentially in the pole position in Japan.“

Pluristem has made the announcement about pursuing opportunities in Japan, and Chairman and CEO Zami Aberman has done an admirable job of executing deals. The company has the partnership with United Therapeutics Corp. (UTHR:NASDAQ), which is conducting a Phase 1 study of the company’s PLX-PAD (full-term placenta-derived adherent stromal cells) product in pulmonary arterial hypertension, which is a fatal disease and happens to be a very large market. Pluristem also has a nice deal in place in Korea with CHA Biotech Co. Ltd. (CHA:KOSDAQ).

Going it alone all the way to market is not a good option for most cell therapy companies, and with the change in the Japanese regulation there is an appetite for regenerative medicine products in Japan that foreign companies in the sector need to capitalize on.

TLSR: You said there were a few others. Give me an overview, please.

RLB: Athersys Inc. (ATHX:NASDAQ) has announced a desire to move into Japan, and I know it is putting boots on the ground in the country to develop a strategy there. Back in January, the company announced some new Japanese patents in graft-versus-host disease (GvHD) and autoimmune diseases, such as inflammatory bowel diseases.

Cytori Therapeutics Inc. (CYTX:NASDAQ) has always had strong relationships in Japan, and has been there for a decade. It has a subsidiary in Tokyo called Cytori Therapeutics K.K.

Also, my own company, RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB), has an existing relationship with Shiseido Company Ltd. (4911:TSE), which will launch a clinical trial in Japan for pattern baldness in the next few months. This is one of the few cell therapy deals—perhaps the only one to date—that involves putting manufacturing capacity in Japan.

“The Japanese government is intentionally welcoming ex-Japan data for conditional market approval in Japan.”

The company that is potentially in the pole position in Japan at the moment, however, may be Mesoblast Ltd. (MSB:ASE; MBLTY:OTCPK). The company inherited a relationship with Japan-based JCR Pharmaceuticals Co. Ltd. (4552:TKY) when, in 2013, it acquired the Prochymal (remestemcel-L or allogeneic, adult human mesenchymal stem cells) product portfolio from Osiris Therapeutics Inc. (OSIR:NASDAQ). The Osiris/JCR partnership, which was put into place a number of years ago, had been stagnant until the reemergence of the Japanese market as an important one for the regenerative medicine sector. Now Mesoblast has “regenerated” that relationship, and announced on Oct. 1 that JCR would be filing a market approval application for Prochymal in Japan for the treatment of pediatric GvHD, following similar approvals in Canada and New Zealand.

TLSR: Will a company be able to take Phase 2 data generated in the U.S. or Europe or Canada, including positive proof-of-concept and safety data, and submit that in Japan, potentially getting a seven-year conditional approval?

RLB: That’s an important question. The best intelligence I have, based on interacting with people who have been working with the Japanese, including Professor Chris Mason from University College London, indicates the answer is “yes.” The Japanese government is intentionally welcoming ex-Japan data for conditional market approval in Japan.

If a company gets conditional approval to market a product in Japan, it will also have to generate pivotal data outside of Japan, because no patients in Japan will want to risk being involved in a placebo trial when they have the option to buy the product in the marketplace. The end result of the paradigm is that there will continue to be data generated outside of Japan, which will be brought into Japan to support eventual final approval.

TLSR: Thank you for your time.

RLB: Many thanks to you.

[Editor’s Note: Between the time this interview was scheduled and the time it was conducted, Buckler left his consultancy firm to become vice president of business and corporate development at Vancouver-based RepliCel Life Sciences Inc., a cell therapy company.]

R. Lee Buckler, vice president of business and corporate development at RepliCel Life Sciences Inc., has been an executive in the cell therapy sector since 2000, beginning with Malachite Management in the Stem Cell Technologies group of companies. Most recently he was the managing director of Cell Therapy Group, a firm he formed in 2008 to do business development consulting for companies and organizations working in or interested in the cell therapy sector. His work included deal-targeting, transactions, market intelligence, competitive analyses, strategic assessments and market profile planning for companies ranging from top-tier multinationals to start-ups. 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. Buckler has a bachelor’s degree in education, and a law degree. He is on the editorial advisory boards of the journal Regenerative Medicine and the BioProcess International magazine. He is also co-chair of the Alliance for Regenerative Medicine’s Communications and Education Committee. He is an active industry commentator in publications and in social media and serves on numerous industry advisory boards.
Read what other experts are saying about:

Athersys Inc.
RepliCel Life Sciences Inc.

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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 he provides services to Streetwise Reports as an independent contractor. He owns, or his family owns, shares of the following companies mentioned in this interview: None. 2) R. Lee Buckler: I own, or my family owns, shares of the following companies mentioned in this interview: RepliCel Life Sciences Inc. I personally am, or my family is, paid by the following companies mentioned in this interview: RepliCel Life Sciences Inc. My company has a financial relationship with the following companies mentioned in this interview: None. I was not paid by Streetwise Reports for participating in this interview. Comments and opinions expressed are my own comments and opinions. I determined and had final say over which companies would be included in the interview based on my research, understanding of the sector and interview theme. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview. 3) The following companies mentioned in the interview are sponsors of Streetwise Reports: RepliCel Life Sciences Inc., Athersys Inc. Mesoblast Ltd. is not affiliated with Streetwise Reports. The companies mentioned in this interview were not involved in any aspect of the interview preparation or post-interview editing so the expert could speak independently about the sector. Streetwise Reports does not accept stock in exchange for its services. 4) Interviews are edited for clarity. Streetwise Reports does not make editorial comments or change experts’ statements without their consent. 5) 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. 6) 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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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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To view the article as it appears on Seeking Alpha, click here.

Summary

RepliCel is a rare blend of upside potential and risk mitigation.
The company has a multiple-product approach.
Near-term catalysts should make the stock pop.

While it is rare to find companies that offer a truly disproportionate positive risk-return profile, RepliCel Life Sciences (OTCQB:REPCF, RP.V) is positioned to have significant upside that is well-justified by the associated risks. The opportunity exists largely because the company is small and essentially unknown – its small size and low daily trading volume represent the most serious risk factors for investors to consider. As the company stands on the cusp of several catalytic events, however, RepliCel is positioned for a meaningful move that will benefit investors.

Who is RepliCel?

RepliCel is in the business of “treating cellular deficiencies” through its proprietary cell reproduction technology, specifically cases of tendonitis, pattern baldness and skin damage. Beyond the technology the company has developed to rapidly reproduce cells for its various treatment protocols, it has developed a delivery injector with addition potential applications. I recently had the opportunity to participate in a meeting directly with company president and CEO David Hall, who emphasized the importance of the diversified product portfolio that his company offers. Because RepliCel is diversified across the fibroblast (collagen-producing), dermal sheath cup (hair producing) and injector lines of business, Hall sees investor risk to be reduced as different lines move ahead.

Source: RepliCel Corporate Presentation August 2013

The general basis of RepliCel’s products is that the company harvest specific cells from the patient, and then uses its proprietary technology to replicate them in sufficient numbers to address the specific deficit. In the case of the tendonitis treatments, this involves creating new collagen cells that allow the damaged area to see improved function and reduced pain by altering the tendon’s basic construction. In the case of baldness treatment, healthy dermal sheath cells allow hair to grow in the needed areas. In both cases, the company’s injector is used to properly introduce the cells into the affected region. RepliCel’s method allows it to produce these cells much faster than competitors.

In early clinical testing, patient safety has been a top concern. In all Phase 1 trials thus far conducted, results were achieved within the required safety parameters. RepliCel is not involved in tradition stem cell therapies, making it less clinically and commercially risky. Part of what makes RepliCel unique, and particularly attractive from an investment standpoint, is that because the company is not using adult stem cells in its protocols, the regulatory burden falls on the low-end of the spectrum. The primary thrust of RepliCel’s treatments are in cosmetic and non-critical areas. While these do not tend to be of huge medical significance – although they can be – the revenue generating potential is there. This is one of the hallmarks of its current mandate to prove up its products to attract a buyer.

The fibroblast protocols have had statistically significant early results in treating various types of tendonitis (See below). In the Phase 1 trial, cell growth increases while pain decreased. Similar tests and Phase 2 testing are moving ahead for tendonitis in the elbow as well. This same technology is moving to Phase 1 trials for treating skin damaged by aging, UV exposure and lifestyle factors. Ultimately, each of these conditions alone represent a significant advance against currently available options, and are in sizeable markets.

Source: RepliCel Corporate Presentation August 2013

Improved Baldness Treatment

In terms of the company’s baldness treatment, Phase 1 showed positive results in less time than the currently available options. While micro-transplant surgery is the current gold standard – it is expensive and highly dependent on the surgeon – Rogaine and Propecia are the most commonly used options currently. Rogaine has shown 8%-16% density increases over 12 months with topical treatment, and Propecia has shown 7%-14% increases over 12 months with an oral regimen. The Phase 1 RepliCel treatment showed an average 11.3% density gain, with 70% achieving over a 10% gain, with the over 10% group averaging 14.3%. The most significant difference with the RepliCel protocol is the end point. Where Rogaine and Propecia require continued use to maintain gains, after the RepliCel injections, gains remain in place. This is a significant point of differentiation.

Catalysts

A highlight for RepliCel from the investment prospective is that the management team is keenly focused on building shareholder value. Hall is targeting and projecting a takeout scenario within 24 months, with major catalysts building value on that path. The biggest driving factor there is new results from the ongoing clinical trials. As each sets a small step-up for the company in terms of the development of a fully saleable product, share price should be significantly impacted.

Along this path, RepliCel already has a key partnership in place with Shiseido, the fourth-largest cosmetics company in the world. The agreement, inked in 2013, provided RepliCel with $35 million, with $4 million upfront and additional fundings at key sales targets. Beyond the capital, Shiseido has built a new cell processing facility that opened in May 2014. The company represents a key strategic partner in terms of both financial strength and reputation. Additionally, this allegiance will allow RepliCel to move quickly in the region as trials for U.S. sales continue. RepliCel continues to seek new partners for other products, each of which, when identified, can serve as a catalyst.

In the near term, there are three different clinical trials beginning in 2014 that should yield the type of data results needed to see the stock move dramatically higher. For example, the planned Phase 2 study on pattern baldness will use a larger test group to establish the lasting efficacy of the treatment, confirming both the safety and effective end date relative to other options. As each of these steps move ahead, RepliCel is well-positioned to move. Hall reports that the company has plenty of cash to complete the clinical trials that are currently planned. He believes that the positive results expected from these will be sufficient to generate the buying interest needed, placing a takeout target within the next 24 months.

The Stock

A definite risk factor of the stock is the very low average trading volume (ADV) of shares. Between shares listed in the U.S. and on the Canadian Venture Exchange, the stock trades less than 100,000 shares per day. This means that the liquidity of any position must be a consideration for any investor making a larger play in the stock. On the other side of things, however, shares are near the bottom of the 52-week trading range. This means that a retracement of even 50% back to that high would represent a dramatic return.

Given the price of shares relative to the potential upside, I believe RepliCel offer an attractive risk-adjusted opportunity to shareholders. There are several catalysts tied to near-term expected milestones that should make the stock move higher. If management can achieve its ultimate goal of a takeout opportunity, shareholders will be well-rewarded. The liquidity risk is real, but the potential here justifies taking some risk.

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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To read the full report click here: RepliCel’s Cutting-Edge Advancements

The following has been published in the Financial Post:

There is enormous interest in the worlds of medicine and esthetics in the promise of regenerative medicine. From cellular replacement techniques for treating Parkinson’s disease to collagen-producing cell injections for wound healing and rejuvenating aging skin, significant steps are being made towards the commercialization of cell therapies. These changes are going to attract major industry players who are constantly on the watch for the latest technologies in development.

Vancouver-based RepliCel Life Sciences Inc. (TSX.V: RP) is a company that is already capturing industry attention. Its unique research into cells from hair follicles could play an integral part in accelerating the repair of tendons, damaged skin and pattern baldness.

David Hall, chief executive officer of RepliCel, describes the premise behind its research as being “elegant in its simplicity.” For example, to treat chronically injured tendons, a patient’s collagen-producing cells (fibroblasts) are isolated from a small biopsy taken from the nape of the patient’s neck, replicated and then injected directly into a damaged tendon to stimulate the stalled healing process leading to structural rehabilitation.

“These isolated fibroblast cells are prolific in their ability to produce Type 1 collagen, the key and missing cell in the stalled healing cycle of a tendon. This same principle holds for aged and sun-damaged skin where the collagen-producing fibroblasts have been damaged by ultraviolet light over time. Our focus is to address indications where there is a deficit of active fibroblasts,” Hall explains. “As injuries occur and people age, their ability to produce collagen and other critical proteins is depleted through repeated injury, sun damage, aging and other factors. Our technology, as it’s proposed, will jump-start the healing process.”

One focus for RepliCel is on clinical trials for chronic tendon injuries, an area of major concern for employers, compensation boards, athletes, active aging populations and the military. Early clinical work using cells isolated from the skin returned excellent results, and RepliCel believes that it has improved the technology even further by using healthier cells isolated from hair follicles. Trials planned for the fall of 2014 will return results in 2015.

The power of the RepliCel approach lies in the fact that treatment utilizes a person’s own cells, thereby reducing risk of complications, notes Lee Buckler, managing director for Cell Therapy Group, a Vancouver-based regenerative industry consulting company. “Taking a patient’s own cells, replicating them in a regulated facility and then returning them to the body minimizes safety risks.”

The markets RepliCel is addressing with their products are significant, he adds. “Their platform, built around two different hair follicle cell populations, could be instrumental in skin applications for burns, acne scarring or aging, in addition to the market for musculoskeletal injuries. It could also play a key role in disrupting the micro-transplant and hair rejuvenation business for pattern baldness.”

Regenerative medicine technologies are now solidly on the radar of big pharmaceutical, biotech and health care companies, Buckler says. “Most life science company executives now believe that cell-based products will represent a new way of delivering therapies to patients. As such, they’re now starting to invest in technologies to make sure they have a horse in the race.”

“Most of the top companies like Pfizer, Janssen, GSK, Novartis, Celgene now have internal and/or external cell therapy programs,” Buckler adds. “Other companies are investing in bringing manufacturing technologies to the sector and even companies not traditionally in health care, like Nestlé and L’Oreal, have established their own research institutes for these cell-based programs. If you look at the industry’s development pipeline, most every condition is being pursued as a target for a cell therapy.”

RepliCel’s current pipeline includes trials for tendinosis, pattern baldness and treatments for aging and sun-damaged skin in various stages of development. Hall estimates that data from the tendon and dermal programs will be available to support licensing discussions by 2015, and pattern baldness in 2016.

“Having this many trials is pretty impressive for a small company,” Hall says. “Our model has always been to develop products, demonstrate efficacy and then license to large pharma or cosmetics firms who can do the final commercialization. We want to be the research and development engine that creates revenues from licences and royalties. In fact, Shiseido Company of Japan has already partnered with us on our pattern baldness product. They acquired an exclusive geographic license for Asia.”

Having spent much of his career researching treatments for tendinosis, Dr. Jack Taunton, professor at the University of British Columbia faculty of medicine’s sports medicine division, says regenerative therapy holds great promise when dealing with chronic, long-term injuries. “We’ve dealt with a number of these types of injuries caused by overuse or repetitive strain in thousands of patients. Typically treatments have included physiotherapy, ice, anti-inflammatory’s, dextrose and PRP [platelet-rich plasma] injections. Yet, we still have a significant population of patients that do not get better.” He is hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

Dr. Ross Davidson, an orthopedic surgeon and director of post-graduate sports medicine at the University of Auckland in New Zealand has treated countless athletes with chronic overuse injuries throughout his career. “I do see a huge potential for this. It has been a pleasant surprise to see the amount of collagen these fibroblasts produce for repairing tendons. It’s a big change from other treatments being released. If it works — and I believe it will — it will reduce the number of surgeries significantly.”

Beyond its clinical trials, the success of RepliCel’s products will be put in the hands of licensing partners which have the infrastructure to support commercialization, says Mark Landy, director of research for senior medical technology and regenerative medicine analyst for Summer Street Research in Boston. The good news is that the industry is not having to wait too long for the clinical trials to get proof of concept. “Having data coming in 2015 and 2016 enables the company to accelerate licensing.”

He believes RepliCel has a significant opportunity ahead given that its regenerative therapy approach addresses extremely large markets that are ready for solutions not provided by today`s treatments. “The industry as a whole has gone beyond the fears around regenerative and genetic engineering and is seeing its value. We now know we can take certain cells from the body and safely put them in certain areas. It’s a notion that goes back to bone marrow transplants and implants. The opportunities — and the markets — for regenerative medicine are very, very large.”

With results from clinical trials on the horizon, Hall is confident things are moving forward as they should. “We’ve been quietly building the fundamentals of this business – forging deals with major players, building up a diversified portfolio and strengthening our management team. Every step we take is incrementally adding value to the shareholders and furthering therapies for patients.”

hopeful that the upcoming RepliCel trials will improve those numbers given that hair follicle fibroblasts produce the amount of Type 1 collagen needed for fundamental repair of the tendon. “The potential to save millions of dollars in treatment of chronic tendon disorders is huge. It’s extremely exciting.”

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

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New in BioWorld, the latest in RepliCel’s cell therapy trials and what they could mean for improving Achilles tendinosis, aging and sun-damaged skin.

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To read the full report click here: Mark Landy on New Growth Ideas for Biotech Investors

The following is an excerpt from The Life Sciences Report, with Mark Landy’s comments on RepliCel:

“RepliCel Life Sciences Inc. is at the forefront of the utilization of stem cells to treat disorders and defects.”

TLSR: Your universe of coverage includes medical technology and regenerative
medicine. Would you talk about some names, please? Do you have a regenerative
medicine story you can share?

ML: While I don’t formally cover RepliCel Life Sciences Inc. (RP:TSX.V;
REPCF:OTCQB), I do find it an interesting and exciting story. I have been doing
diligence on the company to learn more about its technology and opportunities. It
falls into a new category of medicine that is very intriguing to me: regenerative
medicine and gene therapy. RepliCel and another company I follow, Harvard
Apparatus Regenerative Technology Inc. (HART:NASDAQ), are at the forefront of
the utilization of stem cells to treat disorders and defects, which is definitely the
future of medicine.

TLSR: RepliCel has two proposed Phase 2 trials with its RCT-01 (non-bulbar
dermal sheath fibroblasts) cells, which should be initiated before the end of this
year. One trial will be for the Achilles tendinosis indication. I realize that as a Phase
2, this is not designed to be a pivotal trial. But will 82 patients, 41 of whom will
receive RCT-01, be enough to get an indication of efficacy?

ML: To me, the real questions are: What could go wrong and is it safe? My
hypothesis is: Not a whole lot can go wrong and the therapy will be safe, as the
company is using autologous cells. Autologous cells are taken from an individual
and returned to the body. They are a perfect immunological match, and if handled in
a safe and appropriate manner, should not cause the patient any harm. At this
stage, I think what we are all interested in is the safety of RepliCel’s therapy, and I
do not see a lot of risk.

With that said, you are right: The numbers in this study may be too small to determine scientific evidence of efficacy. However, companies like to get some understanding
or signal indicating that there could be efficacy, and they like to learn how to power
larger studies. Also, and more important, in some countries, the pathway to
approval and commercialization for stem cell therapy is being altered so that
companies only need to generate safety data in trials. Then, within a specified
amount of time, they must provide data on efficacy to maintain the therapies on the
market. This is an opportunity that RepliCel can take advantage of, shortening the
cost and time to market in some countries.

TLSR: The other proposed Phase 2 study will be in androgenic alopecia (male
pattern baldness). This study will be with a total of 160 male patients—two
experimental arms, one with 66 single injections and one with 66 repeat injections,
with a 28-patient control arm. What could this trial tell us?

ML: RepliCel could get an indication of efficacy, and could also use this study to
solidify a commercial partner with the financial resources to take the product to
market. This is RepliCel’s strategy: to develop new products and therapies, and
then license the commercial rights to companies with deep pockets and strong
distribution networks.

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Cell therapies for curing alopecia are early in their clinical development. These must still show evidence of durable and robust efficacy. Nevertheless, it bears watching. Regenerative cell therapies are making swift, genuine strides in treating specific human organs such as the hart. We expect these gains to extend towards rejuvenating hair follicles.

Among cell therapy companies in the alopecia space, tiny RepliCel Life Sciences in Vancouver, BC, is furthest into human testing. RepliCel originally started trading on the OTC bulletin board (OTCQB: REPCF) and was recently added to the Toronto Stock Exchange (TSXV: RP)

Replicel Life Sciences is developing its proprietary cell therapy approach designed RCH-01. It aims to rejuvenate damaged, miniaturized hair follicles in balding scalp skin. It focuses on correcting a deficit of healthy dermal sheath cup cells (DSCs) in the follicle.

To read the full excerpt covering RepliCel click here! For more information visit BioWatch News’ website.

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For the full article click here: Alan Leong Interview on Niche Biotech Prospects

life-scineces-report

Read below for an excerpt from Street Wise Reports on Alan Leong’s comments about RepliCel:

TLSR: You mentioned RepliCel in regenerative medicine. Tell me your growth theory for this company.

AL: RepliCel came onto our radar when we were at the Biotech Showcase and JP Morgan Healthcare Conference back in January. The company is very early in development and caught our eye for a couple of reasons.

One, the cells are derived from cells in the hair follicle. Two, the company is competing in less crowded niches—baldness or alopecia, and tendinosis. It’s very interesting that these hair follicle-derived cells appear to have advantageous properties when applied to healing tennis elbow, Achilles tendinosis and similar complaints. The early results are interesting and positive.

“The day is coming in which we will be able to pick a very specific niche or cluster and provide very effective treatments for more defined diseases.”

RepliCel is going to launch two Phase 2 trials this year. For those thinking of investing, the company is in a low-cash position, and is risky. RepliCel behaves like a private company in a lot of ways, because it is raising money to fund some of the next trials. One of the scientists involved with the technology, Kevin McElwee from the University of British Columbia, has an excellent reputation, not just among scientists but also among clinicians who are into hair restoration. Usually, companies joining the regenerative medicine space target major organs and systems. RepliCel, on the other hand, is going after niche indications that give it a much clearer playing field. There was one direct cell therapy competitor, the Aderans Research Institute, out there in the baldness space, but it abandoned the field a few months ago.

TLSR: RepliCel’s technology is autologous. The cells are harvested from the back of the patient’s scalp, and are expanded and processed ex vivo. The harvest and readministration of these cells by injection for alopecia, given that it is a two-step procedure, is about even in clinical complexity to hair plug therapy. Will this therapy for baldness be superior to hair plug therapy, which we know can be painful for the patient?

AL: All things being otherwise equal, patients will be more sold on RepliCel’s therapy than on the hair transplant procedure. With a hair transplant, the physician typically has to implant thousands of units from one part of the head to another. That requires incredible dexterity and takes several hours. In fact, that is why robotics are getting involved—the physician endures incredible repetitive strain. In addition, physicians are digging out not just follicles but a little bit of muscle, too, and placing that into the patient.

Another thing that makes RepliCel’s therapy attractive is that, if you look at surveys or talk to people who are losing hair, the concept of having these injections is very palatable. This possibly could expand the market. Finally, if you look at surveys, the percentage of men who say they would give up a significant portion of their wealth to have their hair restored is astounding.

TLSR: Back on May 20, the company said its licensing partner, Shiseido Company Ltd., was opening a new cell processing facility at the Kobe Biomedical Innovation Cluster in Japan. Does it make sense to process and expand those cells so far away?

AL: Shiseido, a major cosmetics company, is licensing RepliCel’s hair regeneration technology in the largest parts of Asia. It has more than $7B in revenue. In Japan, companies that get involved in pharmaceuticals aren’t like the ones here. For instance, you have major pharmaceutical companies that also make beer, and cosmetic companies doing major research. Shiseido’s new facility is not just a tiny laboratory. It represents a major cell therapy investment. Shiseido’s investment into the collaboration is a form of validation for RepliCel.

TLSR: In mid-June, RepliCel announced it had closed on the third and final tranche of a nonbrokered capital raising that it originally announced at the end of March. Each unit sold for $0.75, and that includes one warrant that could be exercised for $1/share in the first year and $1.25 in year two. The total of these tranches was only about $3.9M, which is not a lot of money. How much dilution are RepliCel investors in for in the future?

AL: It’s a good question, because the dilution could be serious. RepliCel is trying to raise cash in fits and gulps to get it through the next set of trials and raise the company’s valuation. I think that’s part of the rationale behind why the Phase 2 trials are confined in terms of geography. The company wants to put out strong proof of concept and raise the valuation while still making progress on the commercial side. There’s no doubt about it: There’s a balancing act going on here. RepliCel is also trying to raise money through unconventional sources, including governmental sources of funding. We shall see.

TLSR: Alan, I have read that 11 of 12 patients in the Phase 1 Achilles tendinosis trial had what the company calls “satisfactory outcomes,” but those were with adipose-derived cells and not with cells derived from the patient’s hair follicles, which will be used in Phase 2.

AL: That’s correct. The tendinosis indication has had the Phase 1 proof-of-concept study performed, but the Phase 2 study will incorporate some tweaks to the procedure.

TLSR: Is the lead indication at RepliCel Achilles tendinosis or alopecia?

AL: If you asked the company’s CEO, David Hall, I think he would say he’s looking at both of them. Right now, you would have to pick alopecia as positioned to be RepliCel’s lead indication, because a) it has the Phase 2 data, and b) it has the alliance with Shiseido, which also will be advancing work in its labs back in Japan.

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