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.
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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Diagram from RepliCel Company Presentation, February 2017.
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