The purpose of the single center, open-label study will be to determine progression free survival (PFS), pharmacokinetics and safety in glioblastoma multiforme (GBM) patients receiving orally- administered Panzem NCD in combination with Temodar.
Panzem NCD is an orally-administered anticancer agent that attacks tumor cells through apoptosis, tumor cell cycle inhibition and disruption of angiogenesis. The drug is currently being evaluated in multiple phase II studies in patients with a variety of cancers including GBM, prostate cancer, ovarian cancer, carcinoid tumors, and renal cell carcinoma.
Glioblastoma is the most common, and aggressive, form of primary brain tumor. EntreMed has previously presented preclinical data demonstrating that combination treatment with Panzem and Temodar resulted in tumor regression compared to either agent alone in a glioblastoma model.
Carolyn Sidor, EntreMed’s vice president and chief medical officer, said: “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.”