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EntreMed begins phase 2 study of brain tumor drug Panzem NCD
By Angela McDaniels
Seattle, Jan. 19 - EntreMed Inc. said it has begun a phase 2 study for its lead drug candidate, Panzem NCD (2-methoxyestradiol or 2ME2), in patients with recurring glioblastoma multiforme.
Glioblastoma multiforme, also known as grade-IV astrocytoma, is the most aggressive type of primary brain tumor and accounts for an estimated 52% of all primary brain tumors, according to a company news release.
The open-label study will assess the safety, pharmacokinetics and efficacy profile of Panzem NCD, an oral liquid formulation, in 32 refractory or relapsed glioblastoma multiforme patients.
It will be conducted at the Brain Tumor Center at Duke University Medical Center and led by principal investigator David A. Reardon, medical director of clinical research at the center.
"EntreMed plans to initiate several additional phase 2 studies in 2006 in various patient populations, including both single agent and combination studies with other approved anti-cancer therapies," EntreMed vice president and chief medical officer Carolyn F. Sidor said in the release.
EntreMed said Panzem NCD increases the activity of 2ME2, an orally active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor cells.
Phase 1 studies showed that Panzem NCD exhibited anti-tumor activity in animals who received an oral dose of 1,000 mg four times a day, the company said. Additionally, Panzem NCD had an acceptable toxicity profile at this dose and was associated with stable disease and two minor tumor responses.
EntreMed is a clinical-stage pharmaceutical company based in Rockville, Md., that develops therapeutic candidates primarily for the treatment of cancer and inflammation.
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