BioCentury
ARTICLE | Company News

Aeterna partners with CRO on Zoptarelin Phase III

April 11, 2013 12:34 AM UTC

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) partnered with CRO Ergomed Clinical Research Ltd. (London, U.K.) to co-develop Zoptarelin doxorubicin acetate ( AEZS-108) to treat endometrial cancer. Ergomed will be responsible for 30% of the costs for a Phase III trial in the indication that is slated to start this month. In turn, Ergomed is eligible for single-digit royalties on net income for Zoptarelin in the indication. Aeterna said the deal "does not affect [its] strategy of looking for out-licensing opportunities" for Zoptarelin, a doxorubicin chemotherapeutic conjugated to a luteinizing hormone-releasing hormone (LHRH) receptor agonist.

The Phase III trial is slated to enroll about 500 patients to compare Zoptarelin with doxorubicin as second-line therapy for locally advanced, recurrent or metastatic endometrial cancer. Aeterna estimates the clinical and regulatory costs for the trial, for which it has an SPA from FDA, to be about $30 million (see BioCentury Extra, Dec. 28, 2012). ...