SAN DIEGO–(BUSINESS WIRE)–
Cytori Therapeutics, Inc. (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.
To learn more about Kerastem or the STYLE Clinical Trial, please visit www.kerastem.comor https://clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1
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. For more information visit www.cytori.com.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, statements regarding STYLE clinical data and potential benefits to Cytori and its stockholders if Cytori Cell Thearapy is approved for alopecia, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials (including clinical trial conducted by third parties), risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance (including performance under and compliance with the terms of our contracts with such third parties) and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.