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OXiGENE Announces Agreement With FDA On Special Protocol Assessment For A Phase 3 Trial Of ZYBRESTAT(R) In Anaplastic Thyroid Cancer

Stocks in this article: OXGN

SOUTH SAN FRANCISCO, Calif., Sept. 17, 2012 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that it has come to agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid cancer (ATC). The FACT 2 study is designed as a randomized, placebo-controlled, double-blinded study of 300 subjects randomized 1:1 to receive carboplatin and paclitaxel plus fosbretabulin versus carboplatin and paclitaxel plus placebo. The primary endpoint of the study will be to compare the median overall survival between the two arms. 

Commented Peter J. Langecker, M.D., Ph.D., President and Chief Executive Officer: "We appreciate the FDA's granting of the SPA for the pivotal FACT 2 trial of ZYBRESTAT in patients with anaplastic thyroid cancer. ATC is a tough disease – tough for patients who are faced with dire prospects, tough for doctors who have very little to offer in terms of therapy to their patients, tough for the company trying to develop a novel treatment and even tough for regulators who see the need but who also have to see certain criteria met to be able to approve a drug. We want to thank the agency for their very thoughtful and constructive process.

"ATC is the indication for which we have the most compelling data, suggesting an overall survival benefit for patients who receive ZYBRESTAT along with carboplatin and paclitaxel chemotherapy and that is the reason for our continued pursuit of this indication. ATC is a very rare tumor from which most patients die within few months of initial diagnosis, and thus represents a significant unmet medical need. We are hopeful that the receipt of the SPA will strengthen our ability to obtain funding to conduct the FACT 2 study, either through financing or partnering. We believe that vascular disrupting agents can make a valuable contribution to anticancer therapeutic regimens, and we look forward to advancing our VDA programs not only in ATC, but also in ovarian cancer, carcinoid syndrome, myeloid leukemia and other potential indications."

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