RepliCel’s autologous cell therapy candidate to treat hair loss safe in long-term study; shares ease 5% on long … – Seeking Alpha

Thinly traded nano cap ReliCel Life Sciences (OTCQB:REPCF -5.1%) slips after it announced data from a five-year Phase 1 study assessing the safety of its autologous cell therapy for the treatment of androgenic alopecia (pattern baldness), RCH-01. The results were fine, but the timeline for the next study has apparently dampened investors' enthusiasm.

The 19-subject trial met its endpoints thereby confirming the complete safety profile of a high dose of dermal sheath cup cells, administered via injection, for patients with pattern baldness.

Although not powered for efficacy, a treatment effect was observed. The seven best responders experienced at least a 10% increase versus baseline in hair density six months after injection. At month 24, the average hair density increase in the same seven subjects was 8.3%. The top responder showed a 21% increase in hair density at month 24.

The company intends to advance RCH-01 into a Phase 2 study in 160 healthy men with mild-to-moderate pattern baldness. Dermal sheath cup cells will be isolated from a small punch biopsy taken from the back of the subject's scalp. The cells will be replicated and then reintroduced into balding areas. Participants will remain on study for ~39 months.

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RepliCel's autologous cell therapy candidate to treat hair loss safe in long-term study; shares ease 5% on long ... - Seeking Alpha