70 Patient Phase II Trial to Begin Enrollment This Year
Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that Kerastem
Technologies, a wholly owned subsidiary of Bimini Technologies, received
U.S. Food and Drug Administration (FDA) conditional Investigational
Device Exemption (IDE) approval to conduct a clinical trial studying the
safety and feasibility of its technology for the treatment of female and
early male pattern baldness (androgenic alopecia).
The phase II study, known as the STYLE trial, follows initial clinical
work in Europe and Japan. This clinical experience served as a basis for
the FDA IDE submission. The data will be presented in September at the
2015 International Society of Hair Restoration Surgery meeting in
Chicago. STYLE is a 70 patient controlled trial that is expected to
begin enrollment in late 2015 at up to eight (8) centers within the
United States. The primary endpoint is safety and tolerability of the
treatment and secondary endpoints include change in hair growth and
density.
In 2013, Bimini, a private medical technology company, acquired global
and exclusive rights to commercialize Cytori Celution® Technology for
alopecia and hair related indications. Under the commercial agreement,
Bimini will be responsible for all key activities including clinical
studies, regulatory approvals, and market development. Bimini will
acquire Cytori products at agreed upon transfer pricing and pay Cytori a
perpetual royalty on sales.
For more information on the STYLE trial, visit www.kerastem.com
or https://clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1
About Cytori Therapeutics, Inc.
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.
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, those regarding presentation of clinical data and conduct of
clinical trials, as well discharge of product, royalty payment and other
obligations, 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, risks
related to our history of operating losses, the need for further
financing and our ability to access the necessary additional capital for
our business, inherent risk and uncertainty in the protection
intellectual property rights, regulatory uncertainties, risks in the
collection and results of clinical data, final clinical outcomes,
dependence on third party performance, performance 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.
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