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Panzem Granted FDA Orphan Drug Status for Ovarian Cancer
The FDA accepted EntreMed's 2ME2 application upon review of data from preclinical experiments and a Phase I clinical study, together with in vitro data demonstrating that 2ME2 has activity against a variety of ovarian carcinoma cell lines including those resistant to other chemotherapeutic agents. In a Phase I study conducted by the National Cancer Institute with EntreMed's initial formulation of 2ME2, Panzem(R) Capsules, an ovarian cancer patient experienced a durable partial response to 2ME2 after failing three prior chemotherapy regimens.
Carolyn F. Sidor, M.D., EntreMed Vice President and Chief Medical Officer commented on the designation, "Ovarian cancer accounts for 4% of the total cancers in women in the United States. 2ME2 inhibits the proliferation of ovarian carcinoma cell lines in vitro, has antiangiogenic properties, and it binds to tubulin, properties that are important in the treatment of ovarian cancer. We look forward to initiating additional clinical studies to further evaluate 2ME2 alone and in combination with other chemotherapeutic agents in this patient population."
Orphan drug is a designation by the Food and Drug Administration indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Sponsors of drugs granted orphan designation qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act. EntreMed received orphan drug designation previously for 2ME2 in the treatment of multiple myeloma, a type of blood cancer. A 60-patient, Phase II Panzem(R) Capsule study in multiple myeloma, conducted at the Mayo Clinic and the Dana Farber Cancer Institute, has now completed enrollment. Additional clinical studies in multiple myeloma are planned.
About Ovarian Cancer
Ovarian cancer accounts for 4% of all cancers among women in the U.S., and ranks fifth as the cause of cancer deaths. About half of all ovarian cancers occur in post-menopausal women. Ovarian cancer is often asymptomatic in the early stages. As a result, ovarian cancer is often not diagnosed until stage III or IV, where 5-year survival rates decline to 15-20%. Current drug therapy involves paclitaxel and carboplatin/cisplatin regimens. Many patients develop resistance to these drugs, so there is substantial need for innovative therapies that can overcome resistance, either as a single agent or in combination with cytotoxic agents.
Source: EntreMed, Inc.