Celldex reports top-line results from ACT III study Print E-mail
By Staff and Wire Reports   
Saturday, 20 November 2010 16:02

cldxCelldex Therapeutics, Inc. (NASDAQ: CLDX), reported positive top-line data for the primary endpoint of ACT III at the annual meeting of the Society for Neuro-Oncology. According to company officials, the trial met the primary efficacy endpoint.

This is a company we told our readers about in early September. It has emerged as a bio-pharmaceutical that is developing a robust pipeline of innovative, applied immunology product candidates focused on the treatment of cancer and infectious disease. CLDX's Precision Targeted Immunotherapy Platform generates product candidates for clinical development that include therapeutic cancer vaccines, monoclonal antibodies, and vaccines which are targeted to specific markers associated with the underlying disease. 

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The positive top line data they reported was a multi-center, single arm, Phase 2 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."

"This exciting data from ACT III is an important milestone in this fatal disease setting and we look forward to initiating an international, randomized, placebo-controlled Phase 3 clinical trial, which we anticipate will begin in the second half of 2011," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics.

The ACT III data will be discussed in a conference call and webcast presentation on Monday November 22, 2010, from 8:30 to 9:30 am Eastern Time. Lead investigator, Dr. Rose Lai, will participate in the call.

CLDX expects to initiate a Phase 3 in the 2nd half of 2011.

More detailed results from the data which was presented can be found here: http://tinyurl.com/27eq4ua

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