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news.EntreMed has commenced a phase II trial to evaluate the safety and efficacy of its lead drug candidate, Panzem, alone and in combination with Sutent in patients with kidney cancer.
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The study will evaluate the potential of Panzem in patients who have failed treatment with Sutent (sunitinib), as well as patients who are currently being treated with sunitinib, but are showing signs of disease progression.
The combination portion will determine if the addition of Panzem will restore tumor response by blocking tumor growth at both the level of the VEGF receptor and by inhibiting HIF-1alpha.
Renal cell cancers are frequently associated with a mutant or inactive that results in an over expression of VEGF and PDGF through a mechanism involving HIF-1alpha. Panzem inhibits HIF-1alpha and has been shown in preclinical experiments to be both an antiproliferative agent and an antiangiogeneic agent.
“Although great strides have been made in the treatment of renal cell cancer with the approval of tyrosine kinase inhibitors such as sunitinib, patients tolerize to these drugs and eventually progress with their disease,” said Carolyn Sidor, EntreMed vice president and chief medical officer,
Panzem is currently in phase II clinical trials for brain, ovarian, carcinoid, and prostate cancers and a phase I study in metastatic breast cancer.