SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) will present data from its STAR Phase 3 clinical trial describing progress, preliminary blinded patient characteristics, and safety of adipose-derived regenerative cells (ADRCs) for treatment of scleroderma hand dysfunction (clinicaltrials.gov) at the Annual Meeting of the American College of Rheumatology on November 15, 2016.
The poster presentation will describe the STAR clinical trial procedures, patient characteristics, and preliminary blinded safety data for the use of Cytori Cell Therapy in scleroderma patients for the treatment of hand dysfunction. The proposed mechanism of action of the ADRCs prepared with Cytori’s Celution System is postulated to be modulation inflammation, promotion of angiogenesis and prevention of cell apoptosis. Studies suggest that ADRC therapy may change the inflammatory response and augments the regenerative response that starts early in the injury process.
The STAR clinical trial is an 88 subject, double blind trial comparing the effect of Cytori ECCS-50 therapy on hand function as measured by the Cochin Hand Function Score as compared to placebo. Other assessments include Raynaud’s Condition Score, Scleroderma Health Assessment Questionnaire (SHAQ), as well as other evaluations up to 48 weeks. Cytori ECCS-50 therapy is administered subcutaneously directly into the fingers.
“The preliminary data support the feasibility of using Cytori Cell Therapy in scleroderma patients with hand dysfunction,” said Dr. Dinesh Khanna, MD, MS, Frederick G.L. Huetwell Professor of Rheumatology and Professor of Internal Medicine in the Division of Rheumatology, director of the University of Michigan Scleroderma Program and lead author of the poster.
Dr. Marc Hedrick, President and CEO of Cytori, commented, “We remain focused on continuing execution and completion of the STAR study in the middle of 2017.”
Scleroderma, also known as systemic sclerosis, is an autoimmune disease that results in hardening of the skin. There is no known treatment for scleroderma. It is characterized by an excess production of collagen, damage to small blood vessels, and abnormal activation of T lymphocytes. The excess production of collagen may also affect internal organs including the lung, the kidney and the esophagus. The excess production of collagen and damage to blood vessels often results in swelling, skin tightening and breakdown of the skin in the hands causing an inability to perform normal daily activities.
The treatment of hand dysfunction in scleroderma remains an underserved medical need. There is no current approved therapy focused on the improvement of hand dysfunction in scleroderma.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and/or business prospects, which may affect our future operating results and financial position. Such statements, including statements regarding presentation of STAR clinical trial results and completion of the STAR clinical trial, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties, which include inherent uncertainties in conduct of clinical trials and the results of such trials (including risks that the STAR trial or future trials may not support efficacy or safety of Cytori Cell Therapy) are 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.