Cytori Logs Final 48 Week Patient Follow Up Visit In Scleroderma Trial
SAN DIEGO, Calif., May 23, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) ("Cytori" or the "Company"), today announced that it has now completed all 48 week follow up monitoring visits in its U.S. FDA approved Phase III STAR trial. A total of 88 subjects were enrolled and the last subject’s 48 week visit was conducted earlier this week.
STAR is a double-blind, randomized, placebo-controlled, parallel group phase III pivotal study investigating the efficacy and safety of HABEO™ Cell Therapy™on subjects with impaired hand function from scleroderma. The subjects were randomized 1:1 to either HABEO Cell Therapy or placebo. HABEO™ and placebo were administered subcutaneously in subject’s fingers. Final assessments were done at 48 weeks. Upon unblinding and evaluation of the data, subjects who received placebo will be offered participation into the crossover portion of the protocol, using HABEO™ Cell Therapy™, should they desire treatment and continue to qualify. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov
In the United States, the scleroderma affected population appears to be approximately 184 per million, which would represent a market size of aproximately 45,000 scleroderma patients.1 Additionally, in Europe, scleroderma is estimated to have a prevalence between 31 per million and 277 per million which equates to approximately 17,000 to 149,000 scleroderma affected people in the Europe.2
About Cytori Therapeutics
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for 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. Cytori Nanomedicine™ is developing liposome encapsulated therapies for regenerative medicine and oncologic indications. 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, but not limited to, statements regarding Cytori’s conduct of its STAR phase III clinical trial, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include: risks in the conduct of clinical trials; risks associated with potential benefits of our products; risks in the collection and results of clinical data; risks associated with development of our clinical pipeline; final clinical outcomes; regulatory risks and uncertainties; risks related to dependence on third party performance; and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
1. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a large US managed care population.” J Rheum 2012; 38:784-6.
2. Varga, John et al. “Scleroderma: From Pathogenesis to Comprehensive Management.” 2012
Cytori Therapeutics, Inc. Tiago Girao, 1-858-458-0900 ir@cytori.com