FDAnews Drug Daily Bulletin

FDA GRANTS ENTREMED'S CANCER TREATMENT ORPHAN DRUG STATUS

July 10, 2006
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EntreMed's lead drug candidate, Panzem, has been granted orphan drug status by the FDA, the company said.

Panzem (2-methoxyestradiol) is being developed for the treatment of glioblastoma multiforme (GBM), an often fatal form of brain cancer. GBM is the most common type of malignant primary brain tumor, representing approximately 12 to 15 percent of all brain tumors, according to EntreMed.

The FDA accepted the application after reviewing in vitro studies in glioma cell lines that demonstrated anti-proliferative activity of Panzem and in vivo studies in a preclinical model of gliobastoma that demonstrate its anti-tumor activity.

The orphan drug designation is intended to provide incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. and provides the developer with tax credits and marketing exclusivity incentives

Panzem had previously been granted orphan drug status for the treatment of multiple myeloma -- a type of blood cancer -- and ovarian cancer.