Solana Beach, California, April 24, 2019 – Kerastem’s Phase 2 clinical trial in early-stage hair loss patients achieved a statistically significant increase in mean terminal hair count in men with early hair loss when compared to the control group. Based on the results, Kerastem plans to begin a Phase 3 clinical trial later this year.
Kerastem therapy is a one-time treatment that delivers adipose (fat) derived regenerative cells combined with purified fat to the affected area of the scalp. The Phase 2 trial, referred to as the STYLE study, was a U.S. 70 patient, multi-center, randomized, single-blinded, and controlled clinical trial to assess the safety, tolerability, dosing and hair counts in patients with early hair loss.
“Our Phase 2 study showed the Kerastem treatment stimulates hair growth in early stage male hair loss," said Bran Conlan, CEO of Kerastem. "If our Phase 3 trial is successful, more than 40 million people in the United States with early stage hair loss would have a new option."
STUDY RESULTS
- Low dose Adipose Derived Regenerative Cells (ADRCs) + Puregraft fat treatment group achieved a statistically significant increase in mean terminal hair count, when compared to control, in males with early stage hair loss Relative to control, an average increase of 29 terminal (mature) hairs per cm2 of scalp was observed, corresponding to a 17% increase (p < 0.05).
- All treatment arms of STYLE were safe with no serious adverse events reported.
“STYLE indicates that the dosing of this autologous cell product and tissue preparation play a role in achieving a successful outcome," explained Ken Washenik, M.D., Ph.D., principal investigator of STYLE. "To identify the optimal procedure, we designed STYLE to evaluate controls with and without the addition of autologous fat as well as both high and lower doses of ADRCs doses and determined that 500,000 cells per square centimeter resulted in a superior outcome.”
Kerastem’s planned Phase 3 trial will support a Pre-Market Approval (PMA) filing in the United States for males with early hair loss. The company will also explore other product pipeline expansion opportunities including the Kerastem treatment for females with patterned hair loss.
ANDROGENETIC ALOPECIA MARKET SIZE
Hair loss affects more than 40 million men and 21 million women and in the United States alone. The global hair loss treatment market generates more than $7 Billion annually and currently has limited options for men and women with early stage hair loss.
ABOUT KERASTEM
Kerastem is the leader in the development and commercialization of cell-based approaches to hair growth. The company is a wholly owned subsidiary of Bimini Technologies. The Bimini portfolio also includes Puregraft, the world’s leading fat transfer solution.
