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). The results are based on analysis of 44 patients enrolled in the Phase 2 trial. Prior to enrollment in the study, patients had received between 1 and 7 prior lines of chemotherapy and were confirmed to have platinum-resistant ovarian cancer. 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 be 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 Gynecological 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). Dr. Martin Zweifel of the Mount Vernon Cancer Centre, UK, who presented the study results, was awarded a Merit Award by the ASCO Scientific Program Committee in recognition of an outstanding abstract submission. OXiGENE believes these results add to the body of data showing that ZYBRESTAT has activity patients with difficult-to-treat tumors, and suggest that further study in ovarian cancer is warranted.
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