NW Bio’s Phase III Trial of DCVax®-L for GBM Brain Cancer Approved to Proceed in Canada and Under Way at Two Sites
BETHESDA, MD, February 19, 2015 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that 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.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. It has completed enrollment in the Phase I portion of the trial. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company has also received approval of a 5-year Hospital Exemption for the treatment of all gliomas (brain cancer) patients outside the clinical trial.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
Les Goldman Farrell Kramer (Media)