Northwest Biotherapeutics's Phase III Trial With DCVax®-L for Brain Cancer "Adopted" as a National Priority Trial in UK
Published: Apr 16, 2013
BETHESDA, Md., April 16, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), 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.
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," "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 the Company's 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, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy. 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.
SOURCE Northwest Biotherapeutics