Celldex Therapeutics Reports Positive Results from Rindopepimut Phase 2 Brain Cancer Study at SNO 2010 - MarketWatch

Celldex Therapeutics, Inc. today announced the presentation of complete data for the primary endpoint of ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed glioblastoma multiforme (GBM). The data showed 66 percent of patients were progression-free at 8.5 months from diagnosis or 5.5 months from start of vaccination, a statistically significant increase over a predetermined progression-free rate (PFR) estimate. These data are consistent with previous studies (ACTIVATE and ACT II) with rindopepimut in GBM conducted at M.D. Anderson and Duke University. The data were presented at the Annual Meeting of The Society for Neuro-Oncology (SNO) in Montreal, Quebec, Canada. Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule, epidermal growth factor receptor variant III (EGFRvIII).

"These data suggest that rindopepimut is extending survival well beyond what we have seen historically in this patient population," said Rose Lai, M.D., Assistant Professor of Neurology in the Division of Neuro-Oncology, Department of Neurology, Columbia University Medical Center, and lead investigator on the ACT III study. "The consistency of data from three separate studies is impressive and clearly supports the plan to conduct a controlled pivotal study in GBM."
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