Northwest Biotherapeutics And The Fraunhofer Institute For Cell Therapy And Immunology Are Partnering For Clinical Trials And Compassionate Use Cases in Europe
Bethesda, Maryland, May 18, 2011 – Northwest Biotherapeutics (OTC Bulletin Board: NWBO) announced today that it is partnering with Fraunhofer for production of DCVax®-L for brain cancer, for clinical trials and compassionate use cases in Europe. Fraunhofer is the largest applied research foundation in Europe, with a staff of more than 18,000 scientists, engineers, business personnel and others dedicated to practical applications and commercialization of research results, and with annual operations in excess of €1.66 billion ($2.3 billion). Fraunhofer is a highly respected leader in many areas of technology, including cell and immune therapies.
The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in Leipzig, Germany, has dedicated a substantial portion of its state of the art manufacturing facilities to the production of DCVax®, and is assisting NWBT with the applicable regulatory requirements for both clinical trials and compassionate use cases. The Fraunhofer IZI is also selecting and initiating connections with leading clinical centers on behalf of NWBT and its DCVax® products.
This partnering arrangement provides a solid foundation upon which NWBT can proceed with clinical trials in Europe, and with compassionate use treatments of patients in parallel with such clinical trials. In addition, NWBT is eligible for certain grants through the German government which, if approved, can amount to as much as €2 to 3 million ($2.8 to 4.2 million).
“Partnering with such a prestigious institution as the Fraunhofer IZI is both gratifying and exciting,” commented Dr. Alton Boynton, CEO of NWBT. “This partnership can help accelerate the Company’s brain cancer clinical trials program, and also help save lives through compassionate use treatments for other patients while the trials are ongoing.”
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. The Company is developing 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 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 trials in five other cancers. The Company has also conducted a Phase I/II trial with DCVax® 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.
About the Fraunhofer Institute for Cell Therapy and Immunology
The Fraunhofer Institute for Cell Therapy and Immunology IZI is a member of the Fraunhofer Group for Life Sciences. Its objective is to find solutions to specific problems at the interfaces between medicine, life sciences and engineering for partners active in medicine-related industries and businesses. The Institute’s core competencies are to be found in regenerative medicine, or more precisely in cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). In order for the living organism to accept the tissues without any difficulty, it is necessary to study cellular and immunological defense and control mechanisms and take these into account during process and product development. These core competencies entail a multiplicity of tasks to be solved by new products and processes. The Institute works especially closely with hospital institutions, performing quality tests and clinical studies on their behalf. Additionally it also provides assistance in obtaining manufacturing licenses and certifications. www.izi.fraunhofer.de
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax®-Brain and future clinical trials, are forwardlooking 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, are included in the Company’s 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.