EntreMed granted orphan-drug status for Panzem in glioblastoma

By E. Janene Geiss

Philadelphia, June 28 - EntreMed, Inc. said Wednesday that the Food and Drug Administration has granted orphan-drug designation for the company's lead drug candidate, Panzem (2-methoxyestradiol or 2ME2) for the treatment of glioblastoma multiforme, an often fatal form of brain cancer.

The FDA accepted EntreMed's application upon review of data from in vitro studies in glioma cell lines that demonstrate the antiproliferative activity of 2ME2, according to a company news release.

Additionally, results from in vivo studies in a preclinical model of glioblastoma demonstrate antitumor activity of 2ME2.

In January, EntreMed said it began a phase 2 study in patients with glioblastoma multiforme at the Brain Tumor Center at Duke University Medical Center.

Company officials said Panzem has now received orphan-drug status in three cancer indications: gioblastoma, multiple myeloma and ovarian cancer.

Orphan drug is a designation by the FDA 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 is a Rockville, Md., pharmaceutical company focused on cancer and inflammation therapeutics.

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