Cytori Fully Enrols Pivotal US Phase III Scleroderma Trial
Cytori Therapeutics, Inc. announced that its U.S. FDA-approved phase III STAR trial has enrolled its 80th patient (100% of target enrolment). All 80 patients enrolled thus far in both trial arms have been successfully treated without complications. Full trial data are expected to be available in mid-2017.
“The collaboration of our industry, health care professions, health care institutions, and patients has led to our ability to fully enroll the STAR trial ahead of schedule. We are now one step closer to having Cytori Cell Therapy available to patients suffering from hand problems due to scleroderma. It is critical that we remain focused on careful and accurate data collection through the follow-up period. Even though the patients, the investigators, and Cytori remain blinded, we can say that the procedures are feasible and were well-tolerated by the STAR patients,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics.
Strong interest and rapid screening across the multiple trial sites in particular during the peak enrollment period of the last two months will result in additional patients being enrolled into the trial. As a result, final enrollment will exceed the original target of 80 patients. All additional patients have been scheduled such that the final procedure day will occur in early June.
STAR is a randomized, placebo-controlled, double-blind, parallel group, phase III, FDA-approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients have been randomized, with approximately 40 receiving Cytori Cell Therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks' follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. Details of the STAR trial, including inclusion and exclusion criteria, can be found at the following link: clinicaltrials.gov.
The STAR trial follows the French 12-patient, investigator-initiated, open-label SCLERADEC-I pilot trial, which was performed at the Assistance Publique Hôpitaux de Marseille. One year post-treatment results were published in the August 2015 edition of the journal Rheumatology. Data recently presented at the Systemic Sclerosis World Congress indicated that a single administration of ECCS-50 therapy was well-tolerated and that treated patients exhibited significant improvements in hand symptoms, function, and Raynaud's Phenomena through 2 years following treatment.
Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital's budget or country's sickness fund or social security system.
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 regarding events, trends, and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, conduct of Cytori's STAR trial (including enrollment and timely completion of, and availability of data from, the STAR clinical), are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third-party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties 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.
Cytori Therapeutics, Inc.
Tiago Girao, +1 (858) 458.0900
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