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RepliCel's Phase 1 Trial for Hair Loss Completed Successfully

Source: The Life Sciences Report

 

March 17, 2017 (Investorideas.com Newswire) RepliCel's successful conclusion of its Phase 1 trial for hair loss sets it up for the next steps in the drug's development.

Hair cycle

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.

Read what other experts are saying about:

Disclosure:

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.

2) RepliCel Life Sciences Inc. is a billboard sponsor of Streetwise Reports. Streetwise Reports does not accept stock in exchange for its services. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.

4) The article 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. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

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 or article until after it publishes.

Diagram from RepliCel Company Presentation, February 2017.


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