EntreMed begins phase 1b study of Panzem NCD in metastatic breast cancer patients

By E. Janene Geiss

Philadelphia, April 25 - EntreMed, Inc. announced Tuesday the start of a phase 1b study to test its lead clinical-stage drug candidate, Panzem NCD, in combination with paclitaxel (Taxol) in patients with metastatic breast cancer.

The single-center study will be conducted at the Duke University Medical Center under a grant from the Susan G. Komen Breast Cancer Foundation, according to a company news release.

Patients with clinical-stage IV or inoperable stage III breast cancer are expected to be enrolled in the study.

The purpose is to evaluate the biologic effects on tissue and plasma in patients treated with paclitaxel alone and in combination with Panzem NCD (2-methoxyestradiol or 2ME2). The safety and tolerability of Panzem NCD in combination with weekly paclitaxel also will be evaluated, officials said.

Breast cancer remains a significant health problem, killing more than 40,000 American women annually, despite the recent introduction of new therapies.

A primary resistance mechanism is thought to be the upregulation of HIF-1alpha. Prior studies conducted by the Duke team demonstrated that the inhibition of HIF-1alpha causes near-complete destruction of tumor vessels and significantly improved radio-sensitivity in radiation resistant breast tumors.

The inhibition of HIF-1alpha may have the same or similar impact on chemotherapy-resistant tumors, officials said.

Panzem is a potent inhibitor of HIF-1alpha, and its down-regulation is closely associated with 2ME2's tubulin inhibitor properties. HIF-1alpha is over-expressed in more than 70% of human tumors and HIF-1alpha over-expression correlates with tumor aggressiveness, metastases and poor prognosis.

Panzem NCD is a novel anticancer agent, which is part of a next generation of antimitotic cancer drugs that bind to tubulin and work through multiple cellular pathways.

EntreMed is a Rockville, Md., clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation.

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