NW Bio receives MHRA approval to initiate DCVax-L Phase III GBM brain cancer trial in the U.K.

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. 

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 cover certain designated territories, and medical specialties tend to be clustered – which enables heightened efficiencies in clinical trials for diseases such as brain cancer.  

"We are excited and very grateful to the MHRA for its rapid approval, allowing our GBM brain cancer trial to proceed as a Phase III trial in the U.K. as an expansion of the ongoing Phase III trial in the U.S." commented Linda Powers, CEO of NW Bio.  "There is an urgent medical need for better treatment options for GBM, the most lethal form of brain cancer.  We appreciate the opportunity to efficiently include the U.K. in our ongoing Phase III trial, so that we can bring the DCVax®-L immune therapy to patients in the U.K. as well as the U.S."