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Cytori gets FDA nod to resume enrolment in ATHENA cardiovascular trial

Cytori Therapeutics has received notification from the US Food and Drug Administration (FDA) that the company has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials.

According to FDA, the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials.

So far, the company has enrolled a total of 31 patients in the ATHENA trials but enrollment was stopped in May 2013 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, the company started a thorough safety review including evaluating each adverse event in all of its previous and ongoing cardiovascular trials and carried out additional testing of its product and cellular output.

In order to improve the safety of the trial procedures for patients, the company has also implemented several protocol changes.

Cytori president and chief executive officer Dr Marc Hedrick said the company is first and foremost focused on patient safety in all its endeavors, and they are happy to have successfully navigated this issue.

"Such issues are not uncommon in development programs involving novel technology for a severely ill population," Hedrick said.

"Currently, we are assessing what this delay means for this particular trial and will provide an updated plan on our forthcoming quarterly investor call."