AEterna Enters Second Stage of Patient Recruitment for Phase II Cancer Trial
AEterna Zentaris, a biopharmaceutical company, has entered the second stage of patient recruitment for its Phase II trial in endometrial 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 one complete response and two partial responses among 14 patients with a diagnosis of disseminated endometrial cancer. The trial is part of a Phase II program in gynecological cancers for which patient enrollment 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.
Paul Blake, chief medical officer of AEterna Zentaris, said: “We are very pleased with this additional data on the early signal of potential efficacy of our lead oncology compound, AEZS-108 in both endometrial and ovarian cancer.
“The data also strengthens our belief that increased clinical benefit for patients could be achieved by specifically targeting LHRH-receptor expressing tumors using doxorubicin. Finally, this program remains on track and we expect to disclose full results over the next few months.”