SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that information, presented last week in San Francisco, introducing its pivotal scleroderma trial (“the STAR trial”), is now available on the company website at www.Cytori.com. The information session featured Dr. Dinesh Khanna, Frederick G.L. Huetwell Professor of Rheumatology and Associate Professor of Internal Medicine in the Division of Rheumatology, and Director of the Scleroderma Program at the University of Michigan (med.umich.edu/scleroderma). Dr. Khanna is the Principal Investigator of Cytori’s STAR Trial. He has won numerous awards, including the 2007 Spirit of Leadership Award and the 2011 “Best Doctor of the Year” award from the Scleroderma Foundation.
The STAR trial will begin enrolling in 2015 and will include 80 patients in the United States. The trial is a randomized, double-blind, placebo-controlled study of the safety and efficacy of a single administration of Cytori’s lead cellular therapeutic, ECCS-50, in scleroderma patients with hand dysfunction.
“Scleroderma is a rare disease, affecting nearly 300,000 patients in the US. The systemic form, systemic sclerosis, is the focus of the STAR trial and has a prevalence of 60,000 – 70,000 patients. It is an agonizing disease that leads to hand impairment in nearly 90% of patients. Hand symptoms are the leading cause of disability in this patient population, more disabling than rheumatoid arthritis, and severely negatively impact quality of life and work productivity. In addition to general measures to protect the hand, patients require medications, which often are inadequate to control symptoms or prevent complications. This cohort of patients has a dire and unmet need for effective treatments,” explains Dr. Khanna.
The STAR trial is predicated on a completed pilot trial, SCLERADEC-I. In data published in the Annals of the Rheumatic Diseases 2014, patients in SCLERADEC-I showed at six months, on average, after a single treatment of 4 million cells injected into each finger, a 50 percent improvement across four important clinically relevant endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function: improved hand function, decreased pain, improved Raynaud’s phenomena and health related quality of life.1
“The scleroderma patient community anxiously awaits the development of therapeutics that will provide a better quality of life for people with this complex disease. I applaud the work of Cytori Therapeutics and their scientific partners as they work to bring important therapeutic advancements to people living with scleroderma,” said Robert Riggs, CEO of Scleroderma Foundation, Inc.
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 solutions. For more information: visit www.cytori.com.
1. Granel B, et al. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial. Ann Rheum Dis 2014; doe:10.1136/annrheumdis-2014-205681
Contacts
Cytori Therapeutics, Inc.
Shawn Richardson, 1.858.875.5279
ir@cytori.com
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