Kerastem Technologies said today it won Investigative Device Exemption approval from the FDA to conduct a clinical trial of its Celution technology used to treat female and early male androgenic alopecia.
The 70-patient phase II Style trial will follow-up on initial clinical work in Europe and Japan that the company used for IDE submission, the company said.
The trial is slated to begin enrollment in late 2015 at 8 centers across the U.S., with a primary endpoint of safety and tolerability and secondary endpoints including change in hair growth and density, Kerastem said.
“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. As principal investigator of the Style trial, I look forward to evaluating this exciting new approach to the treatment of hair loss,” principal investigator Dr. Ken Washenik of the New York University School of Medicine said in a press release.
San Diego, Calif.-based Kerastem owns the commercialization rights to Cytori Therapeutics (NASDAQ:CYTX) Celution technology for treating alopecia, which Kerastem’s parent company Bimini bought in 2013, according to Cytori.
“The hair market has few acceptable solutions for early hair loss, particularly in women. Style represents a defined clinical pathway in the United States and complements our commercial efforts in Europe and Asia,” Kerastem CEO Bradford Conlan said in a press release.
