The “STAR” pivotal trial that will test Cytori Cell Therapy as a potential treatment for impaired hand function in scleroderma patients has been granted final approval for its application for an Investigational Device Exemption (IDE). The decision, which was made by a division of the U.S. Food and Drug Administration (FDA) called the Center for Biologics Evaluation and Research (CBER), was announced in a press release by Cytori Therapeutics, Inc., a late stage cell therapy company that will conduct the trial.
Given the FDA’s final approval of the STAR trial, Cytori Therapeutics will start enrolling 80 scleroderma patients for the study later this year in about 12 U.S. centers. The randomized, double-blind, placebo-controlled trial will seek to assess the safety and efficacy of Cytori’s lead cellular therapeutic, ECCS-50, in a single administration to patients who suffer from scleroderma and have hand dysfunction.
Cytori Therapeutics aims to improve the quality of life of patients struggling with hand function impairment, as it is usually progressive and can cause chronic pain, blood flow changes and often serious disability. However, the currently available treatments for the condition have few outcomes, and the ones directed to patients with advanced disease often imply significant adverse effects.
“We are pleased to be one step closer to bringing cell therapy into the mainstream of medicine,” said the President and CEO of Cytori Therapeutics, Marc H. Hedrick, M.D. “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.”
Dinesh Khanna, M.D., M.S., an internationally recognized scleroderma expert, is among the investigators responsible for the study and his specialty in leading novel international clinical trials in scleroderma is thought to be crucial for the STAR trial. Being a board certified rheumatologist, he serves as 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, and is also the Clinical Director of UCLA’s Scleroderma Clinic.
“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,” said Shelley Ensz, Founder and President of the International Scleroderma Network. “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.”
Cytori Therapeutics had already presented results from preclinical and clinical studies suggesting the therapy’s ability to improve blood flow, modulate the immune system, and accelerate the wound repair, which enabled a previous decision from the FDA to grant the trial conditional approval. The company expects Cytori Cell Therapy to be able to benefit scleroderma patients across multiple states of the disease, as well as to be offered to clinicians and patients at the point-of-care through Cytori’s proprietary solutions.
The company has announced an informational session about the STAR trial presented by Khanna, on Wednesday, January 14, 2015 from 1:30 PM to 4:30 PM, at the Prescott Hotel, 545 Post Street, San Francisco, in order to provide more information on the treatment and patient enrollment. More information on how to attend the event is possible by contacting Shawn Richardson at [email protected]. The live audio webcast will be available under the investor relations section of Cytori’s website here for a 90-day period.
In addition, Cytori on Monday hosted a presentation on current corporate activities and developments, as well as the recent announcement, which is also available on its website. The company is going to be present at a highly recognized investor conference, the Biotech Showcase 2015 Conference, to provide information on the STAR trial to more than 1700 public and private investors, and pharmaceutical executives.