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Celldex Announces Expansion Of Phase 2 ReACT Study In Recurrent Glioblastoma

Stocks in this article: CLDX

PHILLIPSBURG, N.J., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) Celldex Therapeutics recently completed enrollment in an initial cohort (n=25) of Avastin ® (bevacizumab) refractory patients in the Company's ongoing ReACT study of rindopepimut in EGFR vIII (v3)-positive glioblastoma (GBM). Based on early evidence of anti-tumor activity, including stable disease, tumor shrinkage and investigator-reported response, the Company has decided to add an expansion cohort of approximately 75 patients to better characterize the potential activity of rindopepimut in this refractory patient population. Enrollment in the expansion cohort has begun and, like the initial cohort, will evaluate rindopepimut plus Avastin.

"Patients with GBM who have become refractory to Avastin tend to have very rapid disease progression," said Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. "Based upon preliminary evidence that rindopepimut may have activity in Avastin refractory GBM, we have decided to expand the refractory group with the hope of better defining possible therapeutic effect. We expect to share a formal review of the results from the initial 25 patients at the Society for Neuro-Oncology Annual Meeting in November."

ReACT is a Phase 2 study designed to determine if adding rindopepimut to the standard of care for recurrent glioblastoma, Avastin, improves the outcomes for patients with recurrent EGFR vIII-positive glioblastoma. As amended, the ReACT study will now enroll approximately 170 patients across three groups:

  • Group 1 - Avastin naïve, n= apx. 70, enrollment ongoing—patients randomized to receive either rindopepimut or KLH (administered as a control), each along with Avastin  
  • Group 2 - Avastin refractory, n= apx. 25, enrollment completed—patients receive rindopepimut plus Avastin in a single treatment arm  
  • Group 2C (C = Confirmatory) - Avastin refractory expansion, n = apx. 75, enrollment initiated—patients receive rindopepimut plus Avastin in a single treatment arm

Study endpoints include 6 month progression free survival rate, objective response rate, overall survival and safety and tolerability. 

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