Northwest bio provides update on DCVAX®-L cancer trial

Amendment Accepted By FDA, Enhancing and Upgrading the Trial 41 US Clinical Trial Sites Now In Operation.

BETHESDA, MD, May 17 (Sharewellnewswire.com ) - Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) announced today that it now has 41 clinical trial sites open and recruiting across the United States in its ongoing clinical trial of DCVax®-L immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer.  This is ahead of the Company’s previous projection of 40 sites by the end of Q2, 2012.  The Company plans to continue adding clinical trial sites in the US and Europe, and expects to have at least 60 sites open and enrolling by the end of Q3, 2012. 

The Company also announced that the FDA has accepted an amendment of the clinical trial, which does not make any change in the treatment regimen, which leaves all data collected to date intact for use in the trial’s overall results, and which includes the following: 

Designation as a Phase III trial

Expanded and enhanced statistical endpoint analyses

Addition of another cohort of patients which can potentially expand the application of DCVax®-L, and which increases the trial to up to 300 patients 

Addition of interim analyses for efficacy
A description of the trial protocol as amended will be available at  www.clinicaltrials.gov.

Linda Powers, CEO of Northwest Bio, commented, “Of course, the evolution of this trial to a Phase III trial is no assurance of the outcome, and more than one Phase III trial can often be required for a product approval unless the clinical results are particularly strong.  However, we are pleased to make this transition to Phase III, and believe that the package of amendments further enhances an already strong trial, positioning the Company to realize the potential of the DCVax® technology.”