Cytori Therapeutics says Its ATHENA Study Supports Symptomatic Benefit From Its Cell Therapy

Cytori Therapeutics Inc CYTX revealed the presentation of six, as well as, the twelve month data from the ATHENA studies at the annual meeting of The Society for Cardiovascular Angiography and Interventions. According to the company, its study supported symptomatic gain from its cell therapy. The company indicated that its ATHENA trials were two prospective, randomized (2:1, active : placebo), double-blind, controlled, parallel group trials (ATHENA and ATHENA II) each assessing Cytori Cell Therapy [ATHENA: 20 million cells, 28 patients; ATHENA II: 40 million cells, 3 patients]. Cytori Therapeutics said that its objective of the ATHENA program was the assessment of safety and feasibility of Cytori Cell Therapy with the support of the Celution System automated on-site manufacturing of the cellular therapeutic and intramyocardial delivery for treatment of chronic ischemic heart disease with left heart failure. The company disclosed that a total of 31 patients were randomized before the termination of enrollment, with 28 patients having 6 month or longer follow-up data. The company added that the study enrollment was terminated prematurely due to the prolonged period of enrollment required. Commenting on the developments, Cedars-Sinai Heart Institute's Cardiology Division Director, Tim Henry, said that "The ATHENA data suggest that a small volume fat harvest, followed by automated local processing, and intramyocardial delivery of autologous Cytori Cell Therapy is feasible and may be associated with symptomatic benefit in these patients. Although the sample is size is limited, the findings support feasibility and scalability for use of Cytori Cell Therapy for treatment of ischemic heart disease." On the treatment day, patients underwent fat harvest through small volume lipoharvest followed by cell processing, electromechanical mapping of the left ventricle with subsequent injection of cells or placebo into viable myocardium intramyocardial. Shares of the company traded 1.2% lower on Thursday.