Shares of Canada's AEterna Zentaris ($AEZS) jumped this morning after the biotech announced that the FDA had granted a special protocol assessment for an upcoming Phase III cancer study. The 20% bounce comes 8 months after the biotech's stock was jolted by the late-stage failure of its lead drug, perifosine.
The late-stage flop back in April spurred AEterna to circle the wagons around two other programs, including one for AEZS-108. Just a few weeks ago the developer said that it was beginning the mid-stage portion of a Phase I/II study of 108 for castration- and taxane-resistant prostate cancer. This new Phase III trial will be for endometrial cancer, and the SPA flags the FDA's willingness to consider a submission for approval with the right outcomes.
In the Phase III trial investigators will recruit about 500 patients with metastatic endometrial cancer, offering one study arm a combination of AEZS-108 with doxorubicin. The primary goal will be a classic objective for new cancer drugs: A significant improvement in medial overall survival.
"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for AEZS-108 in endometrial cancer", said AEterna CEO Juergen Engel. "AEZS-108's innovative targeted approach could offer a new treatment option for women with endometrial cancer and provide the company with a significant market opportunity.
- here's the press release