SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 20th patient (25% of target enrollment). In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 10 patients and recommended that the study continue as planned. The 20 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully and well tolerated.
“We are very encouraged by the study progress and the commitment of our study centers to the STAR trial. In addition, we have been able to demonstrate that same day fat harvest, cell processing and finger injection is feasible and has been performed safely in multiple U.S. centers, as was demonstrated in the single center SCLERADEC-I trial performed in France,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics.
STAR is a randomized, placebo-controlled, double-blind, parallel group phase III FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving Cytori Cell Therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. The trial began enrollment in August 2015 with enrollment expected to be completed by mid-2016. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: https://clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5
The STAR trial follows the twelve patient SCLERADEC-I pilot trial in which one year post-treatment results were published in the August 2015 edition of the journal Rheumatology. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through one-year post-treatment.
Top line data announced in December 2015 of two year follow-up were consistent with sustained benefit in patients with hand dysfunction associated with scleroderma treated with Cytori Cell Therapy. The data will be presented at the forthcoming 4th World Systemic Sclerosis World Congress to be held February 18-20, 2016 in Lisbon, Portugal (http://www.sscworldcongress.org).
Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.
About Cytori
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, conduct of Cytori’s STAR trial (including timely completion
of, and availability of data from, the STAR clinical), 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, 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.
