SOUTH SAN FRANCISCO, Calif., March 25, 2016 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that the European Commission has granted orphan drug designation to CA4P for the treatment of gastro-entero-pancreatic neuroendocrine tumors (NETs). The designation provides for ten years of marketing exclusivity in European Union (EU) member countries following product approval. Earlier this year OXiGENE announced that CA4P received orphan drug designation from the U.S. Food and Drug Administration for NETs, which provides for seven years of marketing exclusivity after approval.
“I am pleased that the EU has provided the orphan designation to CA4P for neuroendocrine tumors,” stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. “This designation represents another successful step as we execute on our strategy of bolstering the proprietary position of CA4P in the potential indications in which we are most interested. Separately, we continue to expect final data from our phase 2a clinical trial of CA4P in NETs to be available later in 2016.”
Orphan designation in the EU is granted to product candidates that are intended to treat life-threatening or chronically-debilitating conditions that affect no more than five patients per 10,000 of the EU population. Among other benefits, orphan designation provides for regulatory assistance and scientific advice from the European Medicines Agency during product development.
OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company's investigational drugs include CA4P (fosbretabulin), which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, data and regulatory guidance relative to our clinical programs and achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development, manufacturing and regulatory review, and the availability of additional financing to pursue and continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014.
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