Funding for Manufacturing and for Brain Cancer Trial At 30 Sites In Germany
Bethesda, Maryland, May 1, 2012 – Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO) (NW Bio) today announced that, working together with the Fraunhofer Institute (IZI), it has received approval of a major grant from the Sächsische Aufbau Bank (SAB or Saxony Development Bank) in Germany. The grant will reimburse fifty percent (50%) of the costs for manufacturing in Germany and for NW Bio’s clinical trial with DCVax®-L for brain cancer at up to 30 clinical sites in Germany. The amount of the grant will be €4.15 million (~$5.5 million).
The clinical sites in Germany and their data will become part of the 240-patient, double blind, randomized, placebo-controlled clinical trial for newly diagnosed Glioblastoma multiforme (GBM) brain cancer, which is under way at more than 30 sites across the U.S. The German clinical sites and data will also provide domestic data for European Union (EU) approval processes.
“After working closely for more than 7 months on this grant application process with partners at Fraunhofer IZI, Bioville GmbH, the Translational Center for Regenerative Medicine and Cognate GmbH, we are excited and honored to be awarded one of the largest such R&D grants ever made by the Saxony Development Bank,” commented Linda Powers, CEO of NW Bio. “This award will help us build our base in Germany, and accelerate our brain cancer clinical trial in Europe as well as the US, with some of the most respected institutions on both sides of the Atlantic.”
As noted last week, following recent completion of 13 months of technology transfer and regulatory processes for certification of DCVax®-L manufacturing in Germany, the final regulatory inspection of Fraunhofer IZI’s manufacturing facility is scheduled for June. After the final inspection is successfully completed, manufacturing for the DCVax®-L clinical trial and for Hospital Exemption cases under §4b of the German Drug Act (i.e., compassionate use cases) will be ready to begin. To date, 24 of the 30 clinical trial sites in Germany have already been selected and are in varying stages of qualification and preparation.
NW Bio has made a strategic decision to settle in Leipzig, Germany, and establish its subsidiary there. Leipzig is the second largest city in the State of Saxony, and is the home of Fraunhofer IZI. The State of Saxony, and Leipzig in particular, have put a concentrated focus on regenerative medicine and cell therapies (including immune therapies) for nearly a decade, and have become one of the most important centers for such therapies in Europe. This concentration includes the full spectrum of capabilities and infrastructure, from R&D to specialized hospitals and medical centers to manufacturing. Funding for the grant has been provided by the German Federal State of Saxony and the European Union.
Leipzig has also become a leading center for Europe-wide logistics. DHL, a dominant courier service in Europe, recently moved its overall European logistics hub from Belgium to Leipzig. Other general logistics companies, such as Lufthansa Cargo, and specialized couriers, such as World Courier (who specializes in handling and transporting human organs, tissues and blood products), have also established major operations in Leipzig.
With the support of the State of Saxony, NW Bio will have the opportunity to expand its development and long-term marketing activities for DCVax®-L in Europe.
About Northwest Biotherapeutics, Inc.
Northwest Biotherapeutics, Inc. 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 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®-L 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®-L 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.