Cytori Therapeutics (NASDAQ: CYTX) today 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 (MVO 2) during treadmill testing, a reflection of cardiac functional capacity, was sustained in the ADRC treated group but declined in the placebo group at 6 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 MVO 2, 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. Heart disease is the leading killer in the US and Europe. According to the American Heart Association, there are approximately 5.1 million Americans currently living with heart failure. About Cytori Cell Therapy and ADRCs Cytori Cell Therapy is a proprietary formulation of a patient’s own regenerative cells derived from their own adipose (fat) tissue that is delivered in the same surgical procedure using the Company’s Celution® System. Adipose tissue is the richest source of stem and regenerative cells in the body. This mixed population of cells, collectively referred to as ADRCs, is accessible at the point-of-care through the Celution® System for use in the same patient, creating new treatment opportunities for currently unmet medical needs. ADRCs collectively contribute to the healing process via cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.
About CytoriCytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family. 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, but not limited to, those regarding the significance of the perceived benefits of the PRECISE clinical trial results, such as improvements in patient outcomes with respect to maximum oxygen consumption and ability to perform physical activity, potential benefits in directing treatment options such as assist devices or heart transplant, the sustained effects on functional endpoints, and the suggestions that ADRCs may prevent scar tissue from increasing, preserving functional capacity, and that this therapy may have meaningful impacts on the lives of very sick patients are all subject to risks and uncertainties that could cause the results of a more comprehensive clinical trial to differ materially from those presented above. Some of these risks and uncertainties include, but are not limited to, risks related to statistical power of the PRECISE trial, the need for further clinical studies to confirm the above referenced outcomes, inherent risk and uncertainty in the costs and potential variability of outcomes in a pivotal chronic heart disease trial, regulatory uncertainties regarding the collection and results of clinical data, and dependence on third party performance, as well as other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Forms 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.