SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the finding of sustained benefit at two-year follow-up in the SCLERADEC-I trial of Cytori Cell Therapy (ECCS-50) in patients with hand dysfunction associated with scleroderma.
The SCLERADEC-I trial is an investigator-initiated, open-label, 12 patient trial, led by Dr. Brigitte Granel and Dr. Guy Magalon from the Assistance Publique des Hôpitaux de Marseille. A manuscript describing in detail the data from baseline to 12 months follow-up was recently published in the journal Rheumatology [http://rheumatology.oxfordjournals.org/content/early/2015/09/08/rheumatology.kev323.abstract].
The two-year follow up data in the SCLERADEC-I trial, demonstrated sustained improvement in four key endpoints: (1) Cochin Hand Function Score (CHFS), (2) Scleroderma Health Assessment Questionnaire, (3) Raynaud’s Condition Score (which assesses severity of Raynaud’s Phenomenon), and (4) hand pain, as assessed by a standard visual analogue scale.
“It is encouraging to see maintenance of the response in patients treated with Cytori Cell Therapy at a full two years after only a single administration,” said Steven Kesten, MD, Chief Medical Officer at Cytori. “We hope to validate the observations of sustained benefit in the ongoing phase III pivotal trial in the United States.”
Average values at the two-year timeframe for all four of these end points were statistically significantly improved over baseline and similar to improvements observed at one year. As with the previous studies, no safety issues related to Cytori Cell Therapy were reported. These data, along with other endpoints from the SCLERADEC-I trial, will be presented in detail by Dr. Magalon at the 4th Systemic Sclerosis World Congress to be held in Lisbon, Portugal in February, 2016.
Two follow-on, late-stage trials, STAR in the United States, and SCLERADEC-II in France, are currently enrolling patients.
- STAR is an eighty patient randomized, double-blind, placebo-controlled Phase III/Pivotal trial of a single dose of Cytori Cell Therapy (ECCS-50) compared to placebo. Enrollment in the STAR trial began in August of 2015. Details of the trial can be found at: https://clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5
- SCLERADEC-II is a forty patient, multicenter, randomized, double-blinded, controlled trial of a single administration of Cytori Cell Therapy (ECCS-50), compared to placebo. Enrollment in the trial began in October 2015. Full details of the SCLERADEC-II trial can be found at: https://clinicaltrials.gov/ct2/show/NCT02558543?term=SCLERADEC&rank=1
Systemic sclerosis (SSc) or scleroderma is a rare disease that leads to hand impairment in nearly 90% of patients. In addition to general measures to protect the hand, patients require medications which often are inadequate to control symptoms or prevent complications. This patient population has a dire unmet need for effective treatments. The prevalence in Europe is approximately 100,000 patients and in the US is approximately 50,000 patients.
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 technologies and products. For more information visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements that involve known and unknown risks and uncertainties. Some of these risks include preclinical, clinical and regulatory uncertainties, such as those associated with results of our clinical trials and benefits of our Cytori Cell Therapy, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, included in our annual and quarterly reports. There may be events in the future that we are unable to predict, or over which we have no control, and our business, financial condition, results of operations and prospects may change in the future. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless we have an obligation under U.S. Federal securities laws to do so.