BETHESDA, Maryland, May 26, 2011 /PRNewswire/ --
- Addition of Clinical Sites Ahead of Projections
Northwest Biotherapeutics (OTC.BB: NWBO) today announced that it has accelerated the addition of clinical trial sites, exceeding its projections for the doubling of such sites across the U.S. this calendar quarter, for enrollment of new patients into the Company's ongoing 240-patient randomized, double blind, placebo controlled clinical trial of DCVax(R) immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer.
The Company previously announced 4 clinical sites for new enrollment into the ongoing trial, located in Rochester, Cleveland, Detroit and Minneapolis. The Company has now added New York City (NYU) and Los Angeles (UCLA). In addition, the Company is nearing completion on 4 further sites, in New Jersey, Michigan, Texas and Washington. As a result, the Company expects to have a total of 10 clinical trial sites for new enrollment into its GBM brain cancer trial within this calendar quarter. This will substantially exceed the Company's projections in regard to the expansion of the clinical trial this quarter. At least 5 further clinical sites are anticipated to be added in the third quarter of this year, resulting in a total of 15 sites.
"We are gratified to have received such strong interest and cooperation from clinical centers throughout the U.S., and pleased to be ahead of schedule in completing the lengthy and complex institutional processes to make these centers operational for enrollment of additional new patients into our ongoing GBM brain cancer clinical trial," said Dr. Alton Boynton, CEO of NWBT.
In prior clinical trials of DCVax(R) immune therapy for GBM brain cancer, the results were striking: the patients who received DCVax(R) showed a median survival of 3 years, compared with median survival of only 14.6 months with standard of care today (surgery, radiation and chemotherapy). In addition, the patients treated with DCVax(R) did not have recurrence of their tumor for approximately 2 years, on average, as compared with tumor recurrence in just 7 months with standard of care today. Moreover, the patients treated with DCVax(R) did not experience any toxic side effects, in stark contrast to chemotherapies.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for dendritic cell-based vaccines. The Company's lead clinical trial is a 240-patient Phase II trial in newly diagnosed Glioblastoma multiforme ("GBM"), the most aggressive and lethal 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 trials in five other cancers. The Company has also conducted a Phase I/II trial with DCVax(R) for recurrent metastatic ovarian cancer.
For further information about clinical sites and about the Company, please visit the Company's web site at www.nwbio.com.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax(R)-Brain and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," 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