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RepliCel’s Partnership Initiatives Mature into Licensing Negotiations

RepliCel’s Partnership Initiatives Mature into Licensing Negotiations

RepliCel Life Sciences Inc, a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that it anticipates maturing discussions will lead to one or more new partnership agreements in the near-term. The Company’s strategic focus on partnering has resulted in it being currently engaged in multiple negotiations with potential strategic partners.

“The release of our positive clinical data earlier this year and the recent unveiling of our next-generation dermal injector prototypes have aggressively bolstered partnership negotiations,” says RepliCel President and CEO, R. Lee Buckler. “We remain confident of our ability to execute one or more partnerships for the dermal injector on our way to it being CE-marked by mid-2018, and have also generated significant partnership interest in our biologic assets among strong regional players. We believe it is highly likely that one of these will culminate in a partnership transaction in the near-term.”

RepliCel’s partnership strategy is driven by an intent to identify and negotiate transactions with partners prepared to be investors and co-development partners for defined regional markets that will eventually provide access to their established commercial distribution channels.

In Asia, partnership discussions are focused on the Company’s dermatology and tendinopathy programs, as well as the Company’s next-generation dermal injector, which is expected to be European market-ready next year. The Company is working with a Canadian firm specializing in CanadaChina transactions, to move multiple parties in China/Hong Kong through due diligence into term sheet discussions and negotiations.

In Japan, RepliCel is working with CJ Partners, the country’s leading business development experts in regenerative medicine, to explore potential partnerships for its dermatology and tendinopathy programs with potential Japanese industry partners.

The Company’s fibroblast program (underlying RepliCel’s dermatology and tendinopathy programs) has already been the subject of the first stages of review by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

RepliCel is also engaged in a number of other partnership discussions, at various stages of due diligence, in other parts of the world, including the United States, Europe, and the Middle East.

These discussions span the range of the Company’s product portfolio, including the co-development of RCH-01 for men and women with hair loss due to androgenetic alopecia outside of Asia (where it is already exclusively licensed to Shiseido Company).

The partnership discussions are primarily focused on regional licensing and co-development by commercialization partners with strong track records in their region, as well as proven market expertise in dermatology, aesthetics, or orthopedics.

Each is expected to involve material investment (both upfront and upon milestones), as well as the commitment of expertise, capabilities, finances, and infrastructure to the co-development and eventual commercialization of the products under discussion.

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.

Forward-Looking Statements
Certain statements in this news release are forward-looking statements within the meaning of applicable securities laws. 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 status of the Company’s current partnership discussions; the expected results and timing of same, including that the Company anticipates entering into partnership agreements in the near-term; the benefits the Company may obtain from any partnership; the timing in which the Company’s dermal injector is expected to become market-ready; and that each partnership is expected to involve material investment and other components.

Forward-looking 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 may be unable to agree on definitive partnership agreement terms with any party; the risk that any proposed partnership will fail in the due diligence process; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the business of the Company and any potential partners; risks associated with future approvals for clinical trials; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in applicable jurisdictions; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties related to potential litigation; 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.

www.replicel.com


RepliCels Clinical Trial for Hair Loss

RepliCel’s Phase 1 Clinical Trial for Hair Loss Succeeds in Meeting Primary Endpoints

RepliCel Life Sciences Inc, 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  ¾ perhaps most importantly ¾ 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 saftey 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.

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