The FDA accepted EntreMed's application upon review of data from in vitro studies in glioma cell lines that demonstrate the antiproliferative activity of Panzem (2-methoxyestradiol, or 2ME2). Additionally, results from in vivo studies in a preclinical model of glioblastoma demonstrate the antitumor activity of 2ME2.
The drug candidate is currently being investigated in a phase II study in patients with glioblastoma multiforme (GBM) at the Brain Tumor Center at Duke University Medical Center, North Carolina.
The orphan drug designation means EntreMed will qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act.
EntreMed previously received orphan drug designation for 2ME2 in the treatment of multiple myeloma and ovarian cancer.