SOUTH SAN FRANCISCO, Calif., July 18, 2013 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that the European Medicines Agency (EMA) has granted orphan drug designation for ZYBRESTAT® (fosbretabulin tromethamine) for the treatment of ovarian cancer. Orphan drug designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. A disease is defined as rare in the EU if it affects fewer than five in 10,000 people. Granting of orphan drug designation in the EU provides companies with development and commercial incentives, including a period of market exclusivity, access to a centralized review process, protocol assistance (scientific advice) and waiving of marketing and post-marketing authorization fees.
OXiGENE is developing ZYBRESTAT as a potential treatment for patients with advanced ovarian cancer. Data from a randomized, two-arm Phase 2 clinical trial testing the combination of ZYBRESTAT and Avastin® (bevacizumab) to treat patients with advanced ovarian cancer could be available in early 2014, and, if positive, could provide the basis for a registration program.
"Obtaining orphan drug status for ZYBRESTAT in the EU is an important milestone in advancing OXiGENE's clinical strategy in ovarian cancer," said Peter Langecker, M.D., Ph.D., OXiGENE's Chief Executive Officer. "We are particularly excited about the ongoing GOG Phase 2 trial, as it is the first, and currently the only, randomized trial to test an anti-angiogenic therapeutic agent combined with a vascular disrupting agent in ovarian cancer, without including any cytotoxic chemotherapy. Both preclinically and clinically this combination has been shown to result in more significant reduction in blood flow that can starve and kill the tumor than either drug alone. Strategically it is important to note that in the EU Avastin® is already approved for the treatment of ovarian cancer as a single agent. We have been gratified by the broad interest in ZYBRESTAT within the worldwide oncology community, and look forward to advancing this program toward registration, either with the support of a corporate partner or on our own."