SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that its U.S. FDA approved Phase III STAR trial has enrolled and treated its 40th patient (50% of target enrollment). In addition, a pre-specified independent data monitoring committee review of safety data from the initial 20 patients has been conducted and the committee has recommended that the study continue as planned.
“We remain encouraged by how well the trial procedures have been tolerated and how the procedures have been instituted across the 20 study sites around the country. We are grateful to the investigators, research staff and especially the patients who have participated and enabled us to remain on track to complete enrollment in mid-2016,” 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 ECCS-50 therapy injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving ECCS-50 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 on clinicaltrials.gov.
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 two year results have recently been presented at the Systemic Sclerosis World Congress in Lisbon, Portugal. The data indicated that a single administration of ECCS-50 therapy was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through two years following treatment.
Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) also, known as a named patient or compassionate use program, for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. A MAP provides 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 sources of medicine funding varies by country and may be derived from a combination of the government, hospital, insurer and patient.
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, statements regarding patient enrollment in the STAR clinical trial, 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.