OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer

Feb 14 2011

OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it has entered into a Cooperative Research and Development Agreement with the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) to collaborate on the conduct of a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer. Under the terms of the agreement, OXiGENE will provide ZYBRESTAT to NCI for an NCI-sponsored study conducted by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. The aim of the trial will be to determine if the combination of ZYBRESTAT and bevacizumab will enhance anti-tumor effects and further delay tumor progression when compared to bevacizumab alone. OXiGENE anticipates that investigators will initiate enrollment in this Phase 2 study in the first quarter of 2011. The primary endpoint of the study will be progression-free survival, with results expected to become available in early 2013.

Peter J. Langecker, M.D., Ph.D., OXiGENE Chief Executive Officer, commented: "Based on the encouraging data from both an earlier Phase 2 trial of ZYBRESTAT and chemotherapy in platinum-resistant ovarian cancer, and from our FALCON study of ZYBRESTAT plus bevacizumab in non-small cell lung cancer, we have been eager to continue exploration of combination therapy in patients with relapsed ovarian cancer, which is a highly difficult-to-treat disease. The finalization of this agreement is a critical milestone for OXiGENE, and exemplifies our strategy to leverage our assets through collaborations and continue to demonstrate the therapeutic potential of our vascular disrupting agents in major tumor types. We look forward to working with the GOG and NCI/CTEP to bring this new combination to patients."

Investigators from the GOG approached OXiGENE after seeing positive data from a Phase 2 study of ZYBRESTAT and chemotherapy in patients with platinum-resistant ovarian cancer. The study announced today is designed to investigate an alternative approach to treating relapsed ovarian cancer by exclusively targeting tumor vasculature without the use of chemotherapy.

Earlier Positive Phase 2 Data in Ovarian Cancer

OXiGENE reported positive final data from an investigator-sponsored Phase 2 study of ZYBRESTAT in patients with platinum-resistant ovarian cancer at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO). Platinum resistance was defined as disease relapse within 6 months of completing treatment with platinum-based therapy, and the patients enrolled in the study would therefore not have been expected to respond to further treatment with platinum-based therapy. Of 44 patients enrolled in the study, 11 (25%) had confirmed partial responses as determined by the Gynecologic Cancer InterGroup (GCIG) response criteria, i.e., response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria. An additional 4 patients had unconfirmed partial responses, and stable disease responses were reported in an additional 16 patients. The combination regimen of ZYBRESTAT and carboplatin plus paclitaxel chemotherapy was observed to be well-tolerated with approximately half of the patients completing all 6 cycles of therapy. The Phase 2 trial was a single-arm, Simon two-stage design study evaluating the safety and efficacy of the combination of ZYBRESTAT and chemotherapy (carboplatin and paclitaxel).

The OXiGENE, Inc.