On June 10, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CA4P for the treatment of glioma (Press release, OXiGENE, JUN 10, 2016, View Source [SID:1234513183]). 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. Schedule your 30 min Free 1stOncology Demo! 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.
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"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.