OXiGENE Offers Results from Phase 2 Study of CA4P in Recurrent Ovarian Cancer: Study Met Primary Endpoint of Improvement

OXiGENE, Inc.

, a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced the online publication of results from Study GOG-0186I in the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology. This is the first published report of the beneficial effects of combination vascular targeted therapy (VTT) for women with recurrent ovarian cancer. The open-label randomized phase 2 study in the U.S. enrolled a total of 107 patients at 67 sites to receive either CA4P (fosbretabulin) plus bevacizumab (CA4P combination) or bevacizumab alone (control). The Gynecologic Oncology Group (GOG), a member of NRG Oncology, conducted the study with support from the National Cancer Institute. "I'm excited about the therapeutic potential of CA4P when used in combination with bevacizumab for the treatment of recurrent ovarian cancer," stated Bradley J. Monk, M.D., Director of the Division of Gynecologic Oncology at St. Joseph's Hospital and Medical Center and the Principal Investigator of the study. "In this randomized Phase 2 trial, the combination including CA4P prolonged progression free survival (PFS) compared to bevacizumab alone, and preliminary data show it also improved overall survival for these women. In addition, the safety profile of combination vascular targeted therapy, including hypertension, was acceptable with appropriate management. I look forward to further studying this promising therapeutic approach in the upcoming FOCUS trial." As OXiGENE previously reported, the study met its primary endpoint by demonstrating a statistically significant improvement in PFS for patients receiving the CA4P combination compared to the control (7.3 vs 4.8 months, respectively; Hazard Ratio (HR)=0.69; p=0.05 pre-specified one-sided analysis). Treatment emergent adverse events (AEs) associated with the CA4P combination were relatively low, and no serious AEs were observed. The most common AE associated with CA4P combination was hypertension, occurring in 18 patients (35%) compared to 10 patients (20%) in those receiving control (grade 3 and above). New findings from the publication include: Preliminary median overall survival (OS) was longer for patients receiving the CA4P combination than for the control (24.6 vs to 22.0 months, respectively; HR=0.85; data as of April 2015). The improvement in PFS for patients receiving the CA4P combination was greater for patients with measurable disease than it was for patients without measurable disease, suggesting — along with the findings of improved PFS in patients with platinum-resistant disease — that CA4P combination therapy is more effective in those with more advanced disease. Additional key information included in the publication include: More patients receiving the CA4P combination compared to the control were alive and without disease progression at the completion of the study (13 (24.1%) vs. 6 (11.3%), respectively). The relative probability of responding to treatment was 41% greater for the CA4P combination compared to control. Inducing tumor vascular collapse with CA4P and concurrently preventing vessel regrowth with bevacizumab reduced the risk of tumor progression by an estimated 31.5%. "We are very pleased that the data from the GOG-0186I Study are now available for the medical community," stated William D. Schwieterman, M.D., OXiGENE's President and Chief Executive Officer. "The initial results showing an overall survival benefit for CA4P-treated patients potentially signify a much needed therapeutic advance for women with recurrent ovarian cancer, and we look forward to conducting additional analyses on this important outcome as the data mature."