Cytori Publishes ATHENA Trial Data For Chronic Ischemic Cardiovascular Disease

(RTTNews) - Cytori Therapeutics, Inc. (CYTX), a late stage cell therapy company developing autologous cell therapies from adipose tissue, announced Tuesday that the results from the ATHENA Trials have been published and are now available online in Catheterization and Cardiovascular Interventions.

The ATHENA trials are two prospective, randomized, double-blind, controlled, parallel group trials -ATHENA and ATHENA II - each assessing Cytori Cell Therapy. The objective of the ATHENA program was assessment of safety and feasibility of Cytori Cell Therapy using the Celution System for automated on-site manufacturing of the cellular therapeutic and intramyocardial delivery for treatment of chronic ischemic heart disease with left heart failure.

On the treatment day, patients underwent fat harvest via small volume lipoharvest followed by cell processing, electromechanical mapping of the left ventricle with subsequent injection of cells (or placebo) into viable myocardium intramyocardial.

Thirty-one patients (17 Cytori Cell Therapy, 14 placebo) were randomized prior to termination of enrollment, with 28 patients having 6 month or longer follow-up data. Trial enrollment was terminated prior to the planned target (45 patients per trial) due to the prolonged period of enrollment and safety reviews. ATHENA and ATHENA II trial data were combined for analyses.

Regarding safety, 18 of 31 patients (58.1%) were reported to have at least one serious adverse event during the trial.

Major Adverse Cardiovascular Events occurred in 6/17 of ADRC patients and 3/14 of placebo patients. Two fatal events were reported during the trial with both occurring in the Cytori Cell Therapy group.