Cytori Halts Enrollement In Athena Trials Due To Adverse Events; Stock Tanks

(RTTNews) - Cytori Therapeutics Inc (CYTX) Tuesday placed enrollment in the Athena and Athena II cell therapy trials on clinical hold due to concerns over cerebrovascular events, and as a result, does not expect to complete enrollment of the Athena I trial prior to the end of 2014.

Following the announcement, Cytori shares plunged 25 percent in after-hours trade on the Nasdaq.

"The decision to place the trials on hold was based on a safety review of reported cerebrovascular events," Cytori said in a statement.

Elaborating on the cerebrovascular events in the Athena trials, Cytori said symptoms occurred in three patients, of which two patients' symptoms fully resolved within a short period of time and the third patient has had substantial resolution of symptoms.

Such events had not been previously reported in Cytori's other cardiovascular trials and appear to be related in part to the medical co-morbidities in the treated population and the complex nature of the procedures involved in the trial, the company stated.

Cytori said it has been working with the U.S. Food and Drug Administration to understand any adverse events and to take measures to minimize risks to patients.

San Diego, California-based Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical condition

The U.S. Athena and Athena II clinical trials are randomized, double-blind, placebo controlled studies designed to evaluate the safety and feasibility of ADRCs in heart failure patients with ischemic heart disease who are already receiving maximal therapy with no options for revascularization

The procedure involves a fat harvest through small volume liposuction, cardiac catheterization, electromechanical mapping of the heart to determine where to inject ADRCs (or placebo), the actual ADRC (or placebo) injection and related data collection and monitoring activities.

Cytori stock closed Tuesday at $2.10, down $0.01 or 0.47%, on a volume of 204k shares. In after hours, the stock dropped $0.52 or 24.76% at $1.58.