Kerastem’s Phase II STYLE Clinical Trial Actively Enrolling
Company Adds Two Trial Sites In Northeast and Treats Patients In Los Angeles and Miami
San Diego, California, January, 2016 /PRNewswire/ — Kerastem, the worldwide leader in cell-based approaches to hair regeneration, announced today that STYLE, the company’s US phase II clinical study investigating early stage female and male pattern hair loss, has added new trial sites in New York and New Jersey. The STYLE sites in both Los Angeles and Miami have each enrolled and treated their first subject.
The Laser & Skin Surgery Center of New York, under the leadership of Medical Director Dr. Roy Geronomus, is a nationwide leader in offering innovative study options to their patients. According to Dr. Ken Washenik, Principal Investigator of STYLE, “Dr. Geronomus and his colleagues have made considerable scientific contributions over many years and we are thrilled to have their group join the STYLE team.”
In addition, Dr. Mark Glasgold, Director of The Glasgold Surgical Group of Highland Park New Jersey, is a published and recognized expert in the area of fat grafting and its emerging role in regenerative medicine. Added Dr. Washenik, “we are very fortunate to have Dr. Glasgold and his group’s expertise as part of STYLE and look forward to their positive impact on our study.” Both the New York and New Jersey sites are expected to be actively enrolling patients by the end of January.
STYLE is Kerastem’s phase II randomized, blinded, and controlled investigation of Kerastem therapy in early stage female and male pattern baldness. STYLE is approved to enroll up to 70 patients at up to eight (8) centers within the United States.
Outside of the United States, the company 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.com.
About Kerastem Technologies, LLC
Kerastem Technologies, LLC is a leader in the development and commercialization of cell-based approaches to hair loss. The private company is a wholly owned subsidiary of Bimini Technologies and holds global rights to commercialize Cytori Therapeutics, Inc.’s (CYTX) Celution® Technology for alopecia and hair related indications. The Bimini portfolio also includes Puregraft, the world’s leading fat grafting solution.
Cautionary Statement Regarding Forward-Looking Statements
This press release may include “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by phrases such as “will,” “near future,” “positioned,” “provide,” or other words or phrases of similar import that are intended to identify forward-looking statements. Similarly, statements herein that describe Kerastem LLC’s business strategy, outlook, objectives, plans, intentions, or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements, including: the clinical and commercial potential and success of the company’s product line; general economic and business conditions; and other risks and important factors that could cause actual results to differ materially from the forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this announcement, and Kerastem LLC undertakes no obligation to update the forward-looking statements to reflect subsequent events or circumstances after the date on which they were made.