Northwest Biotherapeutics , a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that the Company's Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer has been "adopted" as a national priority trial in the UK, under the "adoption" program managed by the National Institute for Health Research (NIHR), which is part of the UK's National Health System. This "adoption" of the Company's Phase III trial constitutes a significant validation, and also carries with it resources and operational support for the trial sites.
The NIHR maintains a "portfolio" of clinical trials that have been "adopted" as high priorities for the UK. In order to be selected for the NIHR Portfolio, a proposed clinical trial must go through multiple layers of review and evaluation. The evaluation includes the potential significance of the new medical technology being tested, the quality of the trial design, the feasibility of the trial, and numerous other factors.
Trials that are selected ("adopted") for inclusion in the NIHR Portfolio are monitored closely by the NIHR and the trial sites receive several types of financial and operational support. For example, the NIHR provides resources and funding for additional staff (e.g., nurses) at the trial sites to help accelerate the trial. The NIHR also oversees the performance of the sites, and imposes penalties on the sites for shortfalls such as lags in enrollment.
"We understand that it is relatively rare for a small biotech company to have its clinical trial 'adopted' into the NIHR portfolio, especially a Phase III trial," noted Linda Powers, CEO of NW Bio. "This important validation of our trial is an exciting development, and the extra resources and support from the NIHR to the trial sites will be very helpful in accelerating our trial."
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 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I/II trials in multiple other cancers. The Company also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.
