Kerastem Technologies has completed enrollment of STYLE, a US phase II clinical trial investigating early stage female and male pattern hair loss
OREANDA-NEWS. Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that its licensee Kerastem Technologies, LLC, has completed enrollment of STYLE, a US phase II clinical trial investigating early stage female and male pattern hair loss.
“Cytori Cell Therapy is a broadly applicable cell therapeutic platform used now in multiple mid and late stage clinical trials in the US, Japan and Europe. Our partner Kerastem is focused on developing Cytori technology for men and women with alopecia,” said Dr. Marc H. Hedrick, President & CEO of Cytori. “Early proof of concept clinical data has shown promise and Kerastem expects a read out from the trial in approximately one year. This therapy if approved could create a significant value for our stockholders.”
STYLE is a phase II randomized, blinded, and controlled investigation of Kerastem therapy in early stage female and male pattern baldness. A total of four clinical trial sites treated a target enrollment of 70 patients in the United States. The primary endpoint of STYLE is safety and tolerability at six months and subjects will be followed for 12 months. Subjects participating in STYLE received one of four treatment arms, including fat plus ADRCs.
Outside of the United States, Kerastem is actively involved in market development, with Kerastem therapy currently being offered at a number of clinics in Europe & Japan.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products.
Kerastem Technologies, LLC is a private company owned by Bimini Technologies, and holds global rights to commercialize Cytori Cell Therapy for alopecia and hair related indications. The Bimini portfolio of products also includes Puregraft, the world’s leading fat grafting solution.