The FDA accepted EntreMed’s Panzem (2- methoxyestradiol, or 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 Capsules, an ovarian cancer patient experienced a durable partial response to 2ME2 after failing three prior chemotherapy regimens.
Orphan drug is a designation by the FDA indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the US. 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.