EntreMed, Inc. a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, has announced the commencement of a phase II combination study with Panzem NCD (2- methoxyestradiol or 2ME2) and Temodar (temozolomide) in patients with recurrent glioblastoma multiforme (GBM).

Annick Desjardins, MD, FRCPC, Associate in Medicine at the Preston Robert Tisch Brain Tumor Centre at Duke University Medical Centre will serve as principal investigator. The purpose of the single centre, open-label study will be to determine progression free survival (PFS), pharmacokinetics and safety in GBM patients receiving orally-administered Panzem NCD in combination with Temodar.

Panzem NCD is an orally-administered anticancer agent that attacks tumour cells through multiple mechanisms of action (MOA) and blocks the development of new blood vessels that feed tumour cells. Panzem's MOAs include apoptosis (programmed cell death), tumour cell cycle inhibition at the G2/M phase of mitosis, and disruption of angiogenesis through the inhibition of hypoxia inducible factor-1 alpha (HIF-1á), a protein required for angiogenesis and cell survival under stress. By these mechanisms, Panzem has the potential to attack cancer cells through multiple pathways that affect the formation and replication of tumour cells, and can interrupt the formation of blood vessels that nourish tumour cells and sustain tumour growth.

Panzem NCD is currently being evaluated in multiple phase II studies in patients with a variety of cancers including GBM, prostate cancer, ovarian cancer, carcinoid tumours, and renal cell carcinoma. Panzem NCD has been well-tolerated with an acceptable safety profile, allowing it to be combined with other anticancer therapies such as Temodar.

Glioblastoma is an aggressive and highly vascularized disease. EntreMed has previously presented preclinical data demonstrating that combination treatment with Panzem and Temodar resulted in tumour regression compared to either agent alone in a glioblastoma model.

Carolyn F. Sidor, MD, EntreMed vice president and chief medical officer, commented, "Commencement of this phase II study represents a significant milestone in the clinical development plan for Panzem NCD. The rationale for this combination study is based on preclinical results demonstrating substantial tumour regression with Panzem both alone and in combination with Temodar in GBM models. We are currently conducting a single-agent phase II clinical study with Panzem NCD in GBM patients at the Duke Medical Centre. The goal of the new trial is to determine the potential therapeutic benefit of combining Panzem NCD with the current standard of care, Temodar. We anticipate presenting interim clinical data from the single-agent study of Panzem NCD in GBM patients at the ASCO annual meeting to be held June 1-5, 2007."