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Celldex Therapeutics Announces Publication Of Preliminary Data From The Phase 2 ReACT Study To Be Presented At The 18th Annual Scientific Meeting Of The Society For Neuro-Oncology (SNO)

PHILLIPSBURG, N.J., Nov. 11, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that preliminary data from " ReACT: a Phase 2 Study of Rindopepimut Vaccine (CDX-110) Plus Bevacizumab in Relapsed Glioblastoma", was published in the 2013 abstract supplement to the journal Neuro-Oncology; abstracts were also published online at http://neuro-oncology.oxfordjournals.org/ . Data included in the abstract were as of the time of submission (May 2013) and more comprehensive, updated data from the study will be presented by David Reardon, MD, Clinical Director, Center for Neuro-Oncology, Dana Farber Cancer Center and Associate Professor of Medicine, Harvard Medical School during an oral session on Sunday, November 24 from 10:20 am to 12:00 pm PT at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology held in conjunction with the 18th Annual Meeting of the Society for Neuro-Oncology in San Francisco, CA. As previously disclosed, Celldex will issue a press release in concordance with the presentation on November 24 and will host a conference call to review the data on Monday, November 25 at 8:30 am ET.

ReACT is a Phase 2 study designed to determine if adding rindopepimut to standard of care Avastin® (bevacizumab) improves the outcomes for patients with recurrent EGFRvIII-positive glioblastoma. In August, 2013, Celldex announced that enrollment had been completed in an initial cohort (n=25) of Avastin refractory patients and that, based on early evidence of anti-tumor activity, the Company decided to add an expansion cohort of approximately 75 patients (Group 2C) to better characterize the potential activity of rindopepimut in this refractory patient population. As amended, the ReACT study is actively enrolling approximately 170 patients across three groups:

  • Group 1 - Avastin naive, 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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