SOUTH SAN FRANCISCO, Calif., June 10, 2016 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CA4P for the treatment of glioma. The designation provides for seven years of marketing exclusivity following product approval. CA4P has previously received orphan drug designation from the FDA for the treatment of ovarian cancer, neuroendocrine tumors and certain thyroid cancers.
Glioma is a broad category of brain tumors that grow from glial cells, and includes glioblastoma multiforme (GBM), which is particularly aggressive and often spreads quickly. OXiGENE has preclinical data that demonstrate a positive treatment effect of CA4P in GBM models.
“I am pleased that the FDA has provided orphan designation to CA4P for the treatment of glioma,” stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. “While the principal focus of our clinical development program remains on ovarian cancer, we continue to expand the potential indications and improve our proprietary position for CA4P as part of our novel platform of vascular targeted therapies in oncology.”
Orphan designation can be granted by the FDA to product candidates that are intended to treat rare diseases that generally affect fewer than 200,000 people in the United States.
OXiGENE is a biopharmaceutical company seeking to realize the full potential of vascular targeted therapy in orphan oncology indications. Vascular targeted therapy includes vascular disrupting agents (VDAs), such as the investigational drugs that OXiGENE is developing, and anti-angiogenic agents (AAs), a number of which are approved and widely used in oncology indications.
OXiGENE’s VDAs selectively obstruct a tumor’s blood supply without obstructing the blood supply to normal tissues, and treatment with our VDAs has been shown to lead to significant central tumor necrosis. The company believes that the treatment of cancer would be significantly improved if VDAs and AAs are used together, due to their complementary mechanisms of action. In combination, the VDA would occlude the blood vessels in the interior of a tumor while the AA would prevent the formation of new tumor blood vessels.
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, 2015.
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