SOUTH SAN FRANCISCO, Calif., Dec. 17, 2015 (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 OXi4503 for the treatment of acute myeloid leukemia (AML). The designation provides for ten years of marketing exclusivity in EU member countries following product approval. OXi4503 has previously received orphan drug designation from the U.S. Food and Drug Administration, which provides for seven years of marketing exclusivity after approval.
“The European Commission’s decision highlights the need for new AML treatment options and improves the commercial potential of OXi4503,” stated William D. Schwieterman, M.D. President and Chief Executive Officer of OXiGENE. “We have recently put plans in place to accelerate the development of this promising agent by immediately advancing into the next phase of our ongoing phase 1b/2 clinical trial in the U.S., in which OXi4503 will be used in combination with the approved AML drug cytarabine instead of as a stand-alone investigational agent for the treatment of refractory AML.”
Orphan designation in the European Union 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 (VDAs) 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 (AML). 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.
Investor and Media Contact: firstname.lastname@example.org 650-635-7000