CYTORI THERAPEUTICS INC Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that the Center for Biologics Evaluation and Research (CBER), a division of the U.S. Food and Drug Administration (FDA), has given final approval to its application for an Investigational Device Exemption (IDE) to begin a pivotal trial (the “STAR trial”) to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma.
“We are pleased to be one step closer to bringing cell therapy into the mainstream of medicine,” said Marc H. Hedrick, M.D. President and CEO of Cytori Therapeutics. “The pilot trial data showed evidence that our lead therapeutic could substantially improve hand function and overall quality of life in this group of patients that today have limited effective therapeutic options.”
The STAR trial will begin enrolling in 2015 and will include 80 patients, in up to 12 centers 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. The impairment in hand function is typically progressive and can result in chronic pain, blood flow changes and often profound disability. The available treatments often have minimal impact and those for advanced disease are often accompanied by significant adverse effects.
“We are extremely excited about the approval of the STAR trial. Dr. Dinesh Khanna, one of the principal investigators, is a widely respected international scleroderma expert, and his participation is a strong endorsement of this trial. The International Scleroderma Network welcomes this novel therapeutic approach, which aims to improve scleroderma hand function. If this advanced cell therapy by Cytori Therapeutics proves effective, this will represent a unique and deeply needed option for patients,” said Shelley Ensz, Founder and President, International Scleroderma Network.
Dr. Hedrick will provide an update on current corporate activities and developments, including this recently announced STAR trial, at Biotech Showcase on Monday, January 12 at 3:30 PM Pacific Time, in room C-Mission 11 at the Parc 55 Wyndham Hotel, San Francisco.
A live audio webcast of the presentation will be available under the investor relations section of Cytori’s website at www.cytori.com. A replay of the presentation will be available for 90 days following the event. Please connect to Cytori’s website several minutes prior to the start of the webcast to ensure adequate time for any software download that may be necessary.
Additionally, Cytori will be hosting an information session dedicated to its planned STAR trial and scleroderma and featuring Dr. Khanna. The session will be held on Wednesday, January 14, 2015 from 1:30 PM to 4:30 PM, at the Prescott Hotel, 545 Post Street, San Francisco. Please contact Shawn Richardson at ir@Cytori.com for more information.
A live audio webcast of Dr. Khanna’s scleroderma and STAR trial related remarks will also be available under the investor relations section of Cytori’s website at www.cytori.com. A replay of the presentation will be available for 90 days following the event.
About Dr. Dinesh Khanna
Dinesh Khanna, M.D., M.S., Marvin & Betty Danto Research Professor of Connective Tissue Research and Associate Professor of Internal Medicine in the Division of Rheumatology, is the director of the University of Michigan Scleroderma Program. He has also served as Clinical Director of UCLA’s Scleroderma Clinic.
Dr. Khanna is the author of over 160 peer-reviewed publications and book chapters. 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. He is board certified in rheumatology. Dr. Khanna is currently funded by the National Institutes of Health and is particularly interested in the design of clinical trials and assessing patient reported outcomes in patients with scleroderma and leading novel international clinical trials in scleroderma.
Dr. Khanna is a fellow of the American College of Rheumatology. He was elected by his peers to the 2011-2012 Best Doctors in America, which recognizes the area’s top clinicians.
About Biotech Showcase
The Biotech Showcase 2015 Conference (www.ebdgroup.com/bts) is one of the most significant healthcare investor conferences of the year. It is designed to provide private and public biotechnology and life sciences companies the opportunity to present to, and meet with, public and private investors, and pharmaceutical executives. This is the 7th year for the Biotech Showcase. More than 1700 investors and biopharmaceutical executives from around the world are expected to attend.
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.
