RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB) announced that its first-in-human clinical study for its autologous cell therapy for pattern baldness has concluded. The company stated that "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 [pattern baldness]."
These DSCC are the basis for RepliCel's RCH-01 product. RepliCel stated that "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."
RepliCel also noted that "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."
"We have a much greater understanding and opportunity for further insights from the hair density responses recorded in this first-in-human trial," commented 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."
Echelon Wealth Partners analyst Doug Loe noted in a March 14 report that the Phase 1 results are the first of three Phase 1/2 data sets expected from RepliCel in the next few weeks. The other two target tendon repair in Achilles tendinosis and rejuvenation in UV-irradiation-damaged skin.
Loe noted that with the Phase 1 results "there were no serious adverse events reported in any patients for which biopsy data from 6-24 month follow-up were available, and this includes the absence of any local tumor masses or neoplasia arising from the site(s) of RCH-01 injection, as assessed by biopsy analysis."
Loe also commented that the "proportion of responsive patients [is] actually quite high in our view for what was still an early-stage exploratory trial at the time of study commencement. And on efficacy, we now have two-year data to show that RCH-01 had a measurable impact on hair density in a sizable proportion of patients, though we will be interested to see on longer-term follow-up if there were any distinguishing features in non-responders that could inform how RepliCel screens for patients in future Phase II/III RCH-01 studies."
"It is encouraging that RCH-01 impact on hair density, however modest the two-year data were in comparison to six-month data reported earlier, still showed that RCH-01 could sustain cellular activity for at least that long, an encouraging duration in our view for what at the time of study commencement was still an exploratory cell therapy platform," concluded Loe.
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1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or her family owns, shares of the following companies mentioned in this interview: None.
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Diagram from RepliCel Company Presentation, February 2017.
Disclosures from Echelon Wealth Partners, RepliCel Life Sciences, March 14, 2017
ANALYST CERTIFICATION: Douglas Loe, hereby certify that the views expressed in this report accurately reflect my personal views about the subject securities or issuers. I also certify that I have not, am not, and will not receive, directly or indirectly, compensation in exchange for expressing the specific recommendations or views in this report.
Is this an issuer related or industry related publication? Issuer.
Does the Analyst or any member of the Analyst’s household have a financial interest in the securities of the subject issuer? Yes. 1) Is it a long or short position? Yes, and, 2) What type of security is it? Common shares & Warrants
Does the Analyst or household member serve as a Director or Officer or Advisory Board Member of the issuer? No
Does Echelon Wealth Partners Inc. or the Analyst have any actual material conflicts of interest with the issuer? No
Does Echelon Wealth Partners Inc. and/or one or more entities affiliated with Echelon Wealth Partners Inc. beneficially own common shares (or any other class of common equity securities) of this issuer which constitutes more than 1% of the presently issued and outstanding shares of the issuer? No
During the last 12 months, has Echelon Wealth Partners Inc. provided financial advice to and/or, either on its own or as a syndicate member, participated in a public offering, or private placement of securities of this issuer? Yes
During the last 12 months, has Echelon Wealth Partners Inc. received compensation for having provided investment banking or related services to this Issuer? Yes
Hasthe Analyst had an onsite visit with the Issuer within the last 12 months? No
Has the Analyst been compensated for travel expenses incurred as a result of an onsite visit with the Issuer within the last 12 months? No
Has the Analyst received any compensation from the subject company in the past 12 months? No
Is Echelon Wealth Partners Inc. a market maker in the issuer’s securities at the date of this report? No
This research report was prepared by Echelon Wealth Partners Inc., a member of the Investment Industry Regulatory Organization of Canada and the Canadian Investor Protection Fund. This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Echelon Wealth Partners Inc. is not registered as a broker-dealer in the United States. The firm that prepared this report may not be subject to U.S. rules regarding the preparation of research reports and the independence of research analysts.