Hair

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Canadian Technology and Innovation: making strides in the global cell therapy landscape
Another cell therapy rising star, RepliCel Life Sciences, is harnessing the healing properties of hair...
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Is the Age-Old Quest for a Baldness Cure Reaching Its End?
Click here to read the full article and interview as it appears in The New...
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Company Uses Patients' Own Cells to Put an End to Baldness, Aging Skin and Tendon Degeneration
Company Uses Patients' Own Cells To Put An End To Baldness, Aging Skin And Tendon...
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Regenerative medicine: Interview with a game-changing leader
Regenerative medicine is a game-changing area of medicine. It has the potential to fully heal...
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Skin in the Game
To read the full article as it appears on DDN News (08/08/17), click here. ...
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Hair-Raising R&D: RepliCel Developing Autologous Cell Therapy for Baldness
To read the full article as it appears on BioPharma-reporter.com, click here. (7/12/17) ...
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Poised for Success with Positive Clinical Results
To read the full interview as it appears on Costmeticosbr.com.br, click here (7/6/17).
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A New Approach to Treating Hair Loss
To read the full interview as it appears on Technologyworks.com, click here. (6/27/17)
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Your Hair Could Hold The Secret To Mending Your Injured Tendon
To read the full article as it appears on Pridenews.ca , click here (6/27/17)....
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The Latest in Biocellular Regeneration
To read the full article as it appears on TheAestheticChannel.com by Lisette Hilton, click here...
Press Release
RepliCel Collaborates with University of British Columbia to Build World-Class Hair Follicle Cell Data Map
Data from this project expected to take RepliCel’s products to next level of potential commercial...
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Pioneer in Both Biotech & Business Left Noteworthy Legacy
To read the full article as it appears on HuffingtonPost.com by contributing editor, Lee Buckler,...
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Exclusive Interview with RepliCel Life Sciences President and CEO Lee Buckler
To read the full article as it appears on SmarterAnalyst.com by Julie Lamb, click here....
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Cell therapy: Scientific breakthrough treats signs of ageing
To read the full article as it appears on Cosmetics design-asia.com by Natasha Spencer, click...
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RepliCel Developing Autologous Cell Therapies For Skin, Hair and Tendon Regeneration
To read the full interview as it appears on MedicalResearch.com, click here. (4/22/17)
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RepliCel – Stem Cell Therapies Using Your Own Cells
To listen to Podcast and View Transcript on Future Tech Podcast, click here
Press Release
RepliCel’s Phase 1 Clinical Trial For Hair Loss Succeeds In Meeting Primary Endpoints
Five-year safety data firmly establishes product safety and confirms ongoing clinical and product development strategyVANCOUVER,...
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Will 2017 be the year of Cell Therapies?
To read the full article as it appears on The Huffington Post, click here. (1/20/17)While...
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RepliCel – Using Cells for Healing
View featured company Article on Advisor Access click here
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RepliCel CEO Lee Buckler talks to Cantech Letter
View Article by Nick Waddell on Cantech Letter click here (1/11/2017)...
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Another cell therapy rising star, RepliCel Life Sciences, is harnessing the healing properties of hair follicles to address unmet medical needs in acute, chronic and genetic conditions. RepliCel’s product pipeline features a diverse portfolio spanning tendinopathies, pattern baldness, skin damage, and dermal injector medical devices.
READ FULL ARTICLE

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Click here to read the full article and interview as it appears in The New Yorker (06/07/18).

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Company Uses Patients' Own Cells To Put An End To Baldness, Aging Skin And Tendon Degeneration

By Robin Seaton Jefferson

Forbes Magazine. September 29, 2017.

Hollywood has made movies about it. Industries have made billions from it. And if the volume of scripture is any indication, the Almighty God must have placed great value on his creation of the head of human hair. After all, He gave Samson—the strongest man of whom the Bible tells—his immense strength through his hair and declared a woman’s hair \"a glory unto\" her in the 11th chapter of 1 Chorinthians.

Is it any wonder men and women obsess over their hair? And though we may get wiser as we age (a good thing), most of us don’t get hairier—at least not in the places we want to (not a good thing).

But there is a Canadian company who has been working diligently to change that.

To read the full article, please go to the Forbes Magazine article.

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Regenerative medicine is a game-changing area of medicine. It has the potential to fully heal damaged tissues and organs. To find out more about this innovative medical technology we spoke with RepliCel’s CEO, Lee Buckler. Click here to read the full article

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To read the full article as it appears on DDN News (08/08/17), click here.

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To read the full article as it appears on BioPharma-reporter.com, click here. (7/12/17)

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To read the full interview as it appears on Costmeticosbr.com.br, click here (7/6/17).

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To read the full interview as it appears on Technologyworks.com, click here. (6/27/17)

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To read the full article as it appears on Pridenews.ca , click here (6/27/17).

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To read the full article as it appears on TheAestheticChannel.com by Lisette Hilton, click here (6/20/17). Read full article

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Data from this project expected to take RepliCel’s products to next level of potential commercial viability

VANCOUVER, BC – June 13, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”) is pleased to announce it has signed a collaborative research project agreement with the University of British Columbia (“UBC”). The project will be co-lead by the UBC’s Dr. Kevin McElwee and Professor Youwen Zhou.

The project is designed to deliver a gene and protein expression “map” of healthy hair follicle cells expected to be critically important to improving key components of the manufacturing, regulatory, and clinical profile of RepliCel’s cell therapy products.

“We are very excited to be working with UBC on a project we’ve spent considerable time designing to mature our understanding of the cell populations we work with to improve our product manufacturing, clinical outcomes, and assays critical to regulatory approval and commercialization,” stated RepliCel President and CEO, R. Lee Buckler.

This study will examine different cell groups from human hair follicles and look for differences, and similarities, in gene and protein expression. Additionally, the project will analyze array data from select subjects who participated in RepliCel’s phase I/IIa clinical trial of its RCH-01 product in development for the treatment of androgenetic alopecia which completed earlier this year. This includes data from patients who had the best clinical hair growth response at six months and a sustained positive response at 24 months.

In the study with UBC, the gene expression profiles of the cultured cells from these clinical trial subjects who had a strong hair growth response will be compared to the gene expression profile of subjects who had a reduced hair growth response. The analysis is anticipated to allow RepliCel to better identify specific genes with high or low expression in the cultured cells that correspond to strong hair growth promotion.

About Professor Youwen Zhou, M.D., Ph.D.

Dr. Youwen Zhou is a physician scientist who is a Professor at UBC’s Department of Dermatology and Skin Science. He received his BS degree from Nankai University, China, a PhD in Molecular Genetics from the State University of New York, and an MD degree from the University of Toronto. After completing dermatology specialty training at UBC, he joined UBC Faculty of Medicine as a physician scientist in dermatology in 2000, and was promoted to full professor in 2013. He founded the UBC Molecular Medicine Lab and Chieng Genomics Center at Vancouver Coastal Health Research Institute (VCHRI) with infrastructure funding from Canada Foundation for Innovation in 2001. Dr Zhou’s research is centered on biomarkers of skin diseases such as skin lymphoma, melanoma, and vitiligo, using a wide variety of methods and approaches, including genome-wide association studies (GWAS), linkage analysis, next generational sequencing, transcriptional profiling, cellular and animal models, as well as genome editing.

Dr Zhou has published more than 100 articles in journals such as Nature, Cell, Nature Genetics, and Blood, and holds multiple patents in skin lymphoma diagnostic biomarkers. In 2013, Dr Zhou was awarded a Barney Usher Award for Outstanding Achievements in Dermatology Research from the Canadian Dermatology Association. Dr Zhou specializes in the diagnosis and treatment of skin cancers and skin pigmentation disorders, and is a consultant dermatologist at Vancouver General Hospital and British Columbia Cancer Agency. He teaches graduate students, medical students, dermatology residents and postdoctoral fellows. Dr Zhou is the past president of the Canadian Society of Investigative Dermatology, and served as a board member for Canadian Institutes for Health Research (CIHR) Institute of Musculoskeletal Health and Arthritis (IMHA). He is also a grant reviewer for CIHR, the Canadian Dermatology Foundation, and the Natural Sciences Foundation of China.

About Dr. Kevin McElwee, Ph.D.

Dr. Kevin McElwee is an Associate Professor at the UBC’s Department of Dermatology and Skin Sciences and Director of the Hair Research Laboratory at VCHRI. His research is funded by competitive grants awarded by multiple organizations including the Canadian Institutes for Health Research. Dr. McElwee is one of only a small group of research scientists worldwide who studies hair biology and associated diseases. He has worked as a hair research scientist for 19 years and has published over 100 medical journal articles, as well as research abstracts and academic book chapters on hair loss research. Dr. McElwee received his Bachelor of Science degree from the University of Aberdeen, Scotland and his PhD from the University of Dundee, Scotland. Postdoctoral training included three years at the Jackson Laboratory in Maine and four years at the University of Marburg, Germany, studying hair loss diseases and hair biology. Dr. McElwee is a co-discoverer and patent holder of RepliCel’s technology and continues to serve as the Company’s Chief Scientific Officer.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

RepliCel is also developing a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
604-248-8693

info@replicel.com

Forward-looking information

Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the UBC project outlined in this release. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward looking statements in this news release include: statements relating to the statements that (i) data from this project is expected to take RepliCel’s products to next level of potential commercial viability; (ii) the gene and protein expression map will improve key components of the manufacturing, regulatory, and clinical profile of RepliCel’s cell therapy products; and (iii) the results will improve our product manufacturing, clinical outcomes, and assays critical to regulatory approval and commercialization. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2016 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

 

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

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To read the full article as it appears on HuffingtonPost.com by contributing editor, Lee Buckler, click here. (6/9/17)

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To read the full article as it appears on SmarterAnalyst.com by Julie Lamb, click here. (6/8/17)

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To read the full article as it appears on Cosmetics design-asia.com by Natasha Spencer, click here. (5/17/17)

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To read the full interview as it appears on MedicalResearch.com, click here. (4/22/17)

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To listen to Podcast and View Transcript on Future Tech Podcast, click here

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Five-year safety data firmly establishes product safety and confirms ongoing clinical and product development strategy

VANCOUVER, BC – March 14, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced the successful completion of its first-in-human clinical study of the Company’s autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).

The Company reports the trial succesfully met its endpoints and sets the stage for next steps in the ongoing research and development of its product, RCH-01, for the treatment of male and female androgenetic alopecia. “As we march toward commercialization of this product based on this first-in-human data, our aim is to revolutionize the way we prevent, treat, and even reverse hair loss,” stated RepliCel President and CEO, R. Lee Buckler.

Safety
The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia.

These DSCC form the basis for the Company’s RCH-01 product. The long-term safety of DSCC injections was demonstrated through multiple physician, patient and independent measures of local and systemic tolerance including evaluation of adverse events with respect to causality, incidence, severity and seriousness. No serious adverse events were reported over the entire 60.5-month follow-up period of the trial. Local injection tolerance was confirmed with only a few minor scalp irritations reported around injection sites that resolved quickly soon after injection. Furthermore, histopathological evaluation of injection site biopsies taken six, 12, and 24 months after injection did not reveal any pathology that was suggestive of tumour, granuloma or foreign body formation. An analysis of injection site biopsies taken 60.5 months after injection is currently ongoing with results expected in the next few weeks. Long-term systemic safety of RCH-01 was also confirmed as none of the systemic adverse events reported during the extended safety evaluation were related to treatment.

Indications of Potential Efficacy
The trial was designed to gather data related to the product’s potential efficacy through 24 months post-injection, but was not designed for statistical significance related to any efficacy endpoints. The efficacy data collected from all 19 patients, while not statistically significant, provides useful and potentially exciting insights into the product’s potential for the treatment of those with androgenetic alopecia.

“We have a much greater understanding and opportunity for further insights from the hair density responses recorded in this first-in-human trial,” stated RepliCel President and CEO, R. Lee Buckler. “This data will feedback into our R&D programs and help us develop the best possible product and treatment protocol for men and women suffering from androgenetic alopecia.”

The seven top-tier responders in the trial saw >10% increase in hair density at six months post-injection (see May 17, 2012 announcement). At 24 months, the average hair density increase for these same seven participants was 8.3% over baseline, and three of these seven trial participants maintained a >10% increase in density over baseline. The largest increase in hair density over baseline observed in this group was a 21% increase at 24 months.

The top 10 participants reported at least a 5% or greater increase in hair density at six months post-injection with an average increase of 11.8% (as reported in the May 17, 2012 announcement). This group demonstrated a sustained response at 24 months which averaged a 4.2% increase over baseline hair density. While there was a high degree of variability in hair density between individual participants at 24 months post-injection compared to baseline, an overall stabilization of hair loss was observed among all the patients treated per protocol.

Management Commentary
“The purpose of collecting efficacy data in these early-stage trials,” stated RepliCel’s Clinical Consultant, Darrell Panich, “is for our clinical team and management to obtain data that can be used to inform basic decisions about further development, provide provocative insights into the product’s potential, and – perhaps most importantly – provide useful feedback which we can use to drive decisions about process and product development, ongoing research, and future clinical trial parameters.”

“We are very pleased with the unquestionable safety profile of RCH-01,” stated RepliCel’s co-founder and Chief Medical Officer, Dr. Rolf Hoffmann. “Five-year safety follow-up is rare for cell therapy products and demonstrates our commitment to the highest quality of clinical research. Furthermore, the efficacy signals we see validate the research and development strategy we have had in place since we saw the six-month post-injection data in 2012.”

Hoffmann continued: “Over the past 36 months, we have invested a great deal in both basic research and manufacturing optimization which we believe will be critical to minimizing batch-to-batch variability and further improving efficacy. We have invested in process and product development initiatives including a modified tissue culture technique, improved culture media with addition of 12 new ingredients, introduction of a cell activity promoting step, and cryopreservation storage to improve cell stability and viability. We believe these programs have already resulted in a significantly more robust and better-defined product than the one used in this trial by many measures and look forward to translating our continued R&D into next-phase clinical trials in due course.”

“This trial involved the injection of a very high dose of DSCC in order to identify any potential toxicity ceiling in accordance with the primary safety objectives of the trial. The efficacy data we saw in this trial, together with recent animal research data, suggests that long-term survival of injected cells improves both with smaller dose size and with several sessions of injections spaced-out over a set time course to cumulatively increase injected cell numbers,” stated RepliCel’s co-founder and Chief Scientific Officer, Dr. Kevin McElwee. “We expect cell number and long-term cell survival to be correlative with hair density efficacy. Next-phase trials will be designed to test repeated injection sessions with smaller cell doses than were used in this study.”

“Furthermore,” continued McElwee, “with this 24-month post-injection data, and the availability of patient biopsy material and DSCC, we are now able to commence gene expression analysis with a goal of identifying the differences between products which result in superior responses and those that produce less-than-optimal responses. Ultimately, the goal here is to correlate and optimize cell dose and use repeat treatment sessions to achieve peak efficacy in terms of increased hair density.”

“In summary,” stated RepliCel’s President and CEO, R. Lee Buckler, “we are very pleased with the results of this first-in-human study and are excited to move this product forward into the next phases of development.”

Buckler concluded: “The analysis of data collected from this study, and the direction it gives our research and development programs, will support further optimization of the RCH-01 treatment to be evaluated in future phase II clinical trials. This data, combined with results expected next year from the Shiseido-funded study ongoing in Japan, will support future negotiations with regulators and licensees as we march toward RCH-01 commercialization. Additionally, we are confident that using RepliCel’s RCI-02 injection device (currently under development) in future trials will better control the dose, distribution, and depth of injections to the scalp of study participants. We expect this to further positively impact the product’s efficacy and the uniformity of response.”

About the RCH-01 Clinical Trial (2011 – 2017)
The TS001-2009 first-in-human clinical trial was designed to test the safety and efficacy of dermal sheath cup cells (DSCC are the basis for the Company’s current RCH-01 product) in men and women with androgenetic alopecia. The primary protocol objective of the study was to assess the local (at treatment sites) safety profile of injections. Secondary protocol objectives were to assess systemic (whole-body) safety and local efficacy (hair growth at treatment sites). A total of 19 subjects (10 male and nine female) were recruited for the trial and all of them completed 24-month post injection follow-up visits. Seventeen of those patients went on to complete a full five years of extended safety evaluations to provide information on the long-term safety of DSCC injections. For further details about the trial design, endpoints, etc see https://www.clinicaltrials.gov/ct2/show/NCT01286649.

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

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

Forward-Looking Statements
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) that the RCH-01 product will move towards or be commercialized; (ii) that the RCH-01 product will revolutionize the way that hair loss is prevented, treated, and reversed; (iii) that clinical data from a study being conducted in Japan, financed by Shiseido, is expected in 2018; (iv) the Company’s RCI-02 injection device (currently under development) will better control the dose, distribution, and depth of injections to the scalp of study participants and this will positively impact RCH-01’s efficacy and the uniformity of response.

 

These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals for its injection device; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with Shiseido obtaining approval for its clinical trial; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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View featured company Article on Advisor Access click here

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

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

THIRD PARTY CONTENT
Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.