BOTHELL, Wash., Aug. 15 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. announced today that it has taken a key step in initiating its Phase II clinical trial to evaluate DCVax(R)-Brain in patients with Glioblastoma multiforme, by awarding the clinical trial management contract to Synteract (Carlsbad, CA). Synteract will perform full service management of the clinical trial, which is designed and powered as a pivotal trial. DCVax(R)-Brain is a personalized therapeutic cancer vaccine using the patient’s own dendritic cells (immune cells) with the patient’s own tumor biomarkers (antigens).
“We are pleased to be working with Synteract in this important clinical trial given their longstanding expertise in successful clinical trial management,” stated Alton Boynton, Ph.D., President of Northwest Biotherapeutics. “It will be particularly useful, as this Phase II trial has the potential to become one of the first cancer immunotherapies, an entirely new class of treatment for brain cancer.”
Stewart Bieler, Senior Vice President of Clinical Operation and Project Management at Synteract, said, “We are enthusiastic about working with Northwest Biotherapeutics to bring one of the first personalized medicines into a late stage clinical trial -- especially for a disease like brain cancer, for which very few treatments currently exist and for which the prognosis is especially dire.”
This Phase II clinical trial is based on two Phase I clinical trials carried out at UCLA under the direction of Linda Liau, M.D., Ph.D., Associate Professor of Neurosurgery and Director of the Malignant Brain Tumor Program at the UCLA School of Medicine. Dr. Liau will serve as Principal Investigator for the Phase II trial.
Data from the first Phase I clinical trial at UCLA demonstrated that patient survival was more than twice as long for patients receiving DCVax(R)-Brain treatment than for patients receiving either of the two currently FDA-approved therapies.
Data from the second Phase I clinical trial, which began in November 2002, continue to mature and as of August 8th, 2006, the findings appear to be even more striking than the data from the first Phase I trial. For example:
-- 6 of 10 patients are still alive, with median survival not yet reached; -- 5 of these 6 patients continue to be cancer-free, with no recurrence and with median follow-up time of 37 months; -- Survival times in this trial now range up to 44.4 months (and continuing).
Further, details about this ongoing, long-term follow-up data from the second Phase I trial will be presented by NWBT later this month.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines, and therapeutic antibodies. The Company’s three lead product candidates are:
DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which is entering a Phase III clinical trial recently cleared by the FDA; DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of newly diagnosed Glioblastoma multiforme, which is entering a large Phase II clinical trial recently cleared by the FDA; and monoclonal antibodies to CXCR4, which are in late preclinical development for the treatment of cancer. For further information, please visit the company web site at www.nwbio.com .
About Synteract
Established in 1995, Synteract is a privately held, full-service contract research organization, dedicated to meeting the various needs of biotechnology, biomedical, pharmaceutical, and drug industry firms. Based in Carlsbad, CA, the Company provides expertise in a wide range of therapeutic areas and maintains a wealth of knowledge in oncology. Since 2000, Synteract has been a key development shop for web, wireless and voice data solutions that speed the completion of clinical trials and assist in access to clinical trials information. This includes technologies such as electronic data capture (EDC), interactive voice response systems (IVRS), and automated safety tracking and reporting. Synteract has offices in Carlsbad, CA and Philadelphia, PA. For information please visit us at http://www.synteract.com/ .
Statements made in this news release that are not historical facts 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 initiate, and enroll patients in, the planned Phase II trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the clinical trials process, risks related to the Company’s ability to initiate, and enroll patients in, the planned Phase III trial of DCVax(R)-Prostate and complete the trial on a timely basis, and whether DCVax(R)-Prostate or DCVax(R)-Brain will demonstrate safety and efficacy, and the timely performance of third parties. Additional information on these and other factors, which could affect the Company’s results, is included in its Securities and Exchange Commission 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 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.
Northwest Biotherapeutics, Inc.
CONTACT: Lorie Calvo of Northwest Biotherapeutics, Inc., +1-425-608-3008
