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AEterna Enters Second Stage of Patient Recruitment for Phase II Cancer Trial

Posted on: Friday, 3 October 2008, 12:00 CDT

AEterna Zentaris, a biopharmaceutical company, has entered the second stage of patient recruitment for its Phase II trial in ovarian cancer with AEZS-108, a luteinizing hormone-releasing hormone agonist linked to doxorubicin.

The decision to enter the second stage of patient recruitment was taken following recent first stage data reporting two partial responses among patients with a diagnosis of platinum-resistant ovarian cancer. The trial is part of a Phase II program in gynaecological cancers for which patient enrolment began in December 2007.

The open-label, non-comparative multi-center Phase II program will treat up to 82 women with luteinizing hormone-releasing hormone (LHRH)-receptor positive ovarian and endometrial cancerous tumors. The primary endpoint for the program is the partial or complete tumor response rate according to response evaluation criteria in solid tumors (RECIST) or gynaecologic cancer intergroup guidelines.

The program is being conducted in 15 centers in Europe under the supervision of lead investigator, Gunter Emons, managing director of the Georg-August-University, Institute of Gynaecology and Obstetrics in Gottingen, Germany.

Paul Blake, senior vice president and chief medical officer of AEterna Zentaris, said: "We believe that specifically targeting LHRH-receptor expressing tumors using doxorubicin is key to achieving increased clinical benefit for these patients. Finally, we look forward to disclosing full results during the next few months, as they will be pivotal in formulating the next steps in the clinical development of this novel agent."

Source: Datamonitor

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