Northwest Biotherapeutics, a Bethesda, Md.-based biotech, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the U.K. to proceed with the company's 300-patient phase III clinical trial of DCVax-L immune therapy for Glioblastoma multiforme brain cancer (GBM).
The phase III clinical trial is already under way in the U.S., at 41 sites across the country. NW Bio is now expanding the study 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 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.
"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," said 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."