Kerastem receives FDA approval for clinical trial of alopecia treatment

The FDA Center for Biologics Evaluation and Research Office of Cellular, Tissue and Gene Therapies has given conditional approval to Kerastem Technologies to conduct a clinical trial to study the safety and feasibility of its treatment of androgenic alopecia, according to a press release.

The phase 2 STYLE study will be a follow-up trial to initial clinical data from Europe and Japan that was used as the basis for the FDA investigational device exemption submission, according to the release. The controlled trial will include 70 patients and is expected begin enrollment in late 2015 at eight centers throughout the United States, according to the release.

Safety and tolerability of treatment will be primary endpoint, while change in hair growth and density will be secondary endpoints, the release stated.

“I have been heavily involved in the care and research of alopecia patients and treatments for over 20 years, including the use of cellular-based approaches,” Ken Washenik, MD, PhD, medical director, Bosley Medical Group, and clinical assistant professor, department of dermatology, New York University School of Medicine, said in the release. “As principal investigator of the STYLE trial, I look forward to evaluating this exciting approach to the treatment of hair loss.”

The initial clinical data from Europe and Japan will be presented at the 2015 International Society of Hair Restoration in Chicago, according to Kerastem.

Reference: www.kerastem.com