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Reports US

US stock market daily report (March 12, 2014, Wednesday)

March 13, 2014, Thursday, 05:34 GMT | 01:34 EST | 10:04 IST | 12:34 SGT
Contributed by Millennium Traders

OXiGENE, Inc. (OXGN-Nasdaq) announced late Tuesday, positive results from a randomized Phase 2 clinical trial evaluating Avastin(R) (bevacizumab) with or without ZYBRESTAT(R) (fosbretabulin; CA4P) to treat patients with recurrent ovarian cancer. Shares were trading higher by 93% into early afternoon trading.

The phase 2 study is being conducted by the GOG under sponsorship from the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). It is the first and currently only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent, without including any cytotoxic chemotherapy. The therapies occurred every three weeks intravenously and patients were treated until disease progression or adverse effects prohibited further therapy.

Bradley J. Monk, M.D., FACS, FACOG, principal investigator for the trial, and professor and director, Division of Gynecologic Oncology and Department of Obstetrics and Gynecology at the University of Arizona Cancer Center said, "These findings validate both the novel approach and the complementary mechanisms of combining the vascular disrupting agent fosbretabulin and an antiangiogenic agent like bevacizumab in patients with ovarian cancer. This promising combination warrants further evaluation particularly given the significant need for new treatment options in relapsed ovarian cancer."

The GOG protocol 186I enrolled 107 patients with platinum-sensitive and resistant recurrent ovarian cancer at 67 clinical sites throughout the U.S.A. Patients were randomized 1:1 into one of two treatment arms: one arm received Avastin and the second arm received Avastin plus ZYBRESTAT.

Oxigene is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer. Gynecologic Oncology Group protocol 186I met its primary endpoint of a statistically significant increase in progression-free survival (p-value less than 0.05; hazard ratio 0.685) for the combination as compared to bevacizumab alone.

Peter Langecker, M.D., Ph.D., chief executive officer of OXiGENE said, "We are very excited about these positive results and greatly appreciate all the patients who enrolled in this study and the support, resources and commitment of GOG and CTEP to conduct this important program. ZYBRESTAT is the first vascular disrupting agent to show a statistically significant progression-free survival benefit, and we are evaluating next steps to advance this combination to patients in need."

Under a Cooperative Research and Development Agreement (CRADA) with OXiGENE, during the study, ZYBRESTAT is provided to CTEP and bevacizumab is being provided as an investigational agent under a CRADA with Genentech. However, Bevacizumab is not approved to treat women with ovarian cancer in the U.S.; however, it is approved in other countries for treatment of ovarian cancer.

Secondary endpoints in the study include safety, objective response rate (measured according to RECIST criteria) and overall survival. Patients receiving the combination of ZYBRESTAT and Avastin achieved a higher objective response rate, which was not statistically significant. All patients will continue to be followed for overall survival. Consistent with prior clinical experience with ZYBRESTAT, patients in the combination arm experienced a higher incidence of hypertension compared to the control arm. All cases of hypertension were managed with antihypertensive treatments, as specified in the study protocol. It is expected that the full study results will be submitted for presentation at a future scientific meeting.