April 18, 2014 — Cytori Therapeutics announced publication of safety and efficacy data from a 36 month European clinical trial of Cytori Cell Therapy in patients with chronic ischemic heart failure. Final data from the company’s PRECISE trial, a 27-patient, prospective, randomized, double-blind, placebo-controlled, feasibility trial (Phase I/IIA), demonstrated statistically significant differences in cardiac functional capacity between treated and placebo groups and will appear in an upcoming issue of the American Heart Journal. Cytori Cell Therapy is a mixed population of adipose derived regenerative cells (ADRCs) extracted from a patient’s own adipose tissue using Cytori’s proprietary Celution System.
“The PRECISE trial is the first-in-man trial involving the myocardial injection of ADRCs for heart disease,” said Dr. Emerson Perin, co-Principal investigator of the trial. “By demonstrating a strong safety profile and suggesting that the use ADRCs may preserve functional capacity, the data indicates that this therapy may have meaningful impacts on the lives of these very sick patients.”
The publication, co-authored by trial investigators Drs. Emerson C. Perin at Texas Heart Institute, Francisco Fernández-Avilés at Hospital Universitario Gregorio Marañón and others, reported that the procedure was safe, feasible and showed indications of a favorable benefit to risk profile. The study demonstrated that fat harvest through liposuction could be performed safely in cardiac patients. Exercise capacity as reflected by maximum oxygen consumption (MVO2) during treadmill testing, a reflection of cardiac functional capacity, was sustained in the ADRC treated group but declined in the placebo group at six and 18 months. Statistically significant differences were observed between the two groups.
“These results supported the design of the ongoing U.S. Phase II ATHENA trial that is evaluating a similar patient population,” said Steven Kesten, M.D., chief medical officer for Cytori. “We are encouraged by the sustained effects in functional endpoints, particularly MVO2, which is a relevant clinical endpoint in heart disease, and is an aid in directing treatment options, such as assist devices or heart transplant. We look forward to reporting the initial six-month results from the ATHENA trial.”
In addition, the data trends suggest that ADRC therapy may have a modest beneficial effect in scar stabilization. Left ventricular infarcted mass, the size of the scar tissue caused by lack of oxygen, remained consistent in ADRC-treated patients at six months compared to an increase in control patients, suggesting that ADRCs may prevent scar tissue from increasing. Other endpoints such as ventricular volumes and ejection fraction showed inconsistent findings.
In the PRECISE trial, all patients were treated with standard-of-care and subsequently underwent a liposuction procedure. Each patient’s adipose tissue was processed using Cytori’s proprietary Celution System to prepare the cell therapy. Cells (n=21) or placebo (n=6) were injected into areas of the heart muscle that were severely damaged but still viable and reversible using the NOGA XP System.
Cytori is currently enrolling patients in the U.S. ATHENA and ATHENA II trials, both 45 patient prospective, randomized, double-blind, placebo-controlled trials investigating a lower and a higher dose, respectively, of Cytori Cell Therapy in a similar patient population as PRECISE. In addition, Cytori has received a CE mark for the Intravase reagent to be used with the Celution System for intravascular delivery. The Intravase CE mark allows for targeted sales to physicians conducting independent research for intravascular indications. Cytori has a global patent estate related to the treatment of heart disease that includes 48 patents with 521 claims across 28 countries, including multiple countries in Europe, major Asian markets such as Japan and China, as well as other emerging markets.
For more information: www.cytori.com