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Northwest Bio Receives Regulatory Approval To Proceed With Its Phase III Trial In The UK
Date:8/23/2012

BETHESDA, Md., Aug. 23, 2012 /PRNewswire/ -- Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) announced today that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom (the U.K.'s "FDA"), for the Company's 300-patient Phase III clinical trial of DCVax®-L immune therapy for Glioblastoma multiforme brain cancer (GBM) to proceed in the U.K. 

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This Phase III clinical trial is already under way in the U.S., at 41 sites across the country.  NW Bio is now expanding this Phase III trial to make it an international trial, by including clinical trial sites in Europe.  This international approach can potentially save years of time in clinical trials, compared with conducting trials in the U.S. and Europe separately.

NW Bio's submission of the Phase III trial application to the U.K.'s MHRA, as well as the MHRA's acceptance of the trial's designation as a Phase III trial and rapid approval of the trial, mark the culmination of two years of preparatory work and foundation-building in the U.K.

NW Bio has already obtained Ethics Committee approval for this trial on a centralized basis from the National Research Ethics Committee in the U.K.  Such Ethics Committee approval is equivalent to Institutional Review Board (IRB) approvals in the U.S.  This centralized approval from the National Research Ethics Committee applies throughout the U.K., eliminating the need to obtain Ethics Committee (IRB) approvals at each clinical trial site (which typically takes months at each site in the U.S.). 

The U.K. has one of the largest populations in Europe (63 million), nearly equal to that of France (65 million), and exceeded only by Germany (82 million).  Under the U.K.'s National Health System, medical centers cov
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SOURCE Northwest Biotherapeutics, Inc.
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