SOUTH SAN FRANCISCO, Calif., Feb. 14, 2011 (GLOBE NEWSWIRE) -- 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 CancerOXiGENE 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). About the Gynecologic Oncology Group The Gynecologic Oncology Group (GOG) is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. The GOG is one of the National Cancer Institute's funded cooperative groups. The GOG is the only group that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix. The GOG is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers, and administrative personnel.
About ZYBRESTAT (fosbretabulin)ZYBRESTAT is being evaluated in a Phase 2 study of patients with non-small cell lung cancer and other clinical trials. OXiGENE believes that ZYBRESTAT is poised to become an important product in a novel class of small-molecule drug candidates called vascular disrupting agents. Through interaction with vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively targets and collapses tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells. In clinical trials in solid tumors, ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against anaplastic thyroid cancer, ovarian cancer and various other solid tumors. About OXiGENE OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases. The Company's major focus is developing vascular disrupting agents that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients. The OXiGENE, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4969 Safe Harbor Statement This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of new clinical studies, the results of the proposed relapsed ovarian cancer study, and the efficacy of the ZYBRESTAT and bevacizumab combination may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the outcome of clinical studies and the availability of additional financing to continue development of ZYBRESTAT. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
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