Cytori Therapeutics places enrollment in ATHENA, ATHENA II trials on hold Cytori Therapeutics has placed enrollment in the ATHENA and ATHENA II trials on clinical hold and therefore anticipates that it will not be possible to complete enrollment of the ATHENA I trial prior to the end of 2014 as previously anticipated. The decision to place the trials on hold was based on a safety review of reported cerebrovascular events. 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.
Cytori Therapeutics receives FDA approval to resume ATHENA trial enrollment Cytori Therapeutics has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials. The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trials’ internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients. Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytori’s submission was received on October 22.