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NW Bio Provides Guidance On Phase III Trial Enrollment Timing: Completion Expected To Be Faster Or More Efficient Than Relevant Comparison Trials
Date:3/7/2013

BETHESDA, Md., March 7, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it expects to complete enrollment in its 312-patient Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer within a period that is faster or more efficient than relevant comparison trials with immune therapies for the same brain cancer.  The Company anticipates completing enrollment of its Phase III trial by Q1 or early Q2 of next year, and expects to reach its first interim analysis for efficacy by approximately Q3 of this year. 

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Relevant comparisons include the following (according to information publicly reported on www.clinicaltrials.gov and in company announcements and filings):

  • Celldex Therapeutics (NASDAQ: CLDX) is conducting a Phase III trial with 440 patients, at 164 clinical trial sites worldwide, which began enrolling in November 2011, and appears likely to continue enrolling over at least a 4-year period through the end of 2015, with topline results expected at the end of 2016. 
  • Immunocellular Therapeutics (NYSE MKT: IMUC) is conducting a Phase II trial with 124 patients, which were enrolled over the course of 7 calendar quarters from Q1 2011 through Q3 2012.  (IMUC apparently screened 278 patients, but actually enrolled and treated less than half of them:  only 124 patients were enrolled, in aggregate, and treated in either the treatment arm or the placebo arm of the trial.) 
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