|NW Biotherapeutics' Phase III Trial of DCVAX®-L for GBM Brain Cancer Approved to Proceed in Canada; FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf|
|By Josh Gee|
|Thursday, 19 February 2015 19:56|
Northwest Biotherapeutics (NASDAQ: NWBO), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced the Company's ongoing Phase III clinical trial of DCVax-L for Glioblastoma multiforme (GBM) brain cancer has been approved by Health Canada (the Canadian regulatory authority) to proceed in Canada, has completed the approval processes at two sites, and is under way screening patients for enrollment.
The two open trial sites are the Institut et hôpital neurologiques de Montréal (Montreal Neurological Institute and Hospital) and the Centre Hospitalier Universitaire de Sherbrooke, Hôpital Fleurimont, in Sherbrooke, Quebec. The Montreal Neurological Institute and Hospital is the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. It is connected with McGill University, an important research center. The Sherbrooke Hospital is a major regional medical center for Quebec, serving over a million people, and is also a quaternary care center (i.e., a center for advanced and specialized medical treatments).
"We are very pleased to have been given a green light for our Phase III trial of DCVax-L by another highly respected regulator, in Canada, and to again be working with the leading institutions in the country," commented Linda Powers, CEO of NW Bio. "As we have regularly said, adding further countries and trial sites, even as we reach the late stages of our Phase III trial, provides a double benefit: it will help accelerate the completion of the trial and, importantly, it will expand the pool of sites that are trained, experienced and prepared in advance for commercialization of DCVax-L.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by August 11, 2015.
“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it Priority Review status,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”
A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The NDA is based on results of the coBRIM Phase III study, which showed the MEK inhibitor cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half in people who received the combination (hazard ratio [HR]=0.51, 95 percent confidence interval [CI] 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab value abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab value abnormalities.
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