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news.EntreMed has commenced a phase II clinical trial to evaluate the safety and efficacy of its lead clinical-stage drug candidate, Panzem NCD, in combination with Genentech's Avastin in patients with locally advanced or metastatic carcinoid tumors.
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The study sites include the Dana-Farber Cancer Institute, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center and will be conducted under the direction of Dr Matthew Kulke.
Panzem (2ME2) is an orally-active small molecule that attacks tumor cells through multiple mechanisms of action and has antiangiogenic activity. Panzem NCD, a liquid nanocrystal formulation of 2ME2, can attack tumors on multiple fronts – directly by disrupting microtubules, an intracellular matrix necessary for the rapid division of cancer cells (mitosis), by inducing programmed cell death (apoptosis), and by blocking blood vessels that feed tumors (angiogenesis inhibition).
Recent phase Ib studies with Panzem NCD have shown that the pharmacokinetic target for antitumor activity was achieved and, additionally that the drug has an acceptable toxicity profile at the therapeutic dose.
“Patients with metastatic carcinoid tumors have very few effective treatment options. Combination chemotherapy, when used, generally results in a response rate of 10-15%. We believe that combining two agents with antiangiogenic activity represents a unique approach to treatment, and may produce higher response rates than combination chemotherapy or either antiangiogenic agent alone,” said Dr Carolyn Sidor, EntreMed's vice president and chief medical officer.
Panzem NCD is also currently in a phase II clinical trial for brain cancer and a clinical trial in combination with Taxol in metastatic breast cancer, both being conducted at the Duke University Medical Center.