German Regulator Authorizes Northwest Biotherapeutics's Phase III GBM Trial to Open
Published: Sep 17, 2013
BETHESDA, Md., Sept. 17, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that the German regulatory authority (the Paul Ehrlich Institute, or PEI) has approved the Company's implementation of the three minor amendments required by the PEI's initial decision announced in August, and has authorized the Company's Phase III GBM clinical trial to open in Germany.
NW Bio made its submission of the clinical trial documents with the three amendments included on September 5, 2013, and received the PEI's approval on September 16, 2013. The PEI approval letter stated that:
"The documents submitted have been assessed and deemed sufficient to fulfill the additional conditions imposed. As all legal requirements of Sections 40, 42 of the German Medicinal Products Act (AMG) are now complied with, the clinical trial can be started immediately." (English translation of German text).
This rapid regulatory response represents the last step in a long approval process before one of the most rigorous regulators in the world. It enables NW Bio to proceed with its Phase III trial in Germany, where the Company plans to include more than 20 top German hospital centers. These German centers will be joining more than 55 clinical trial sites currently operating in the US, as well as sites in the UK, as part of NW Bio's international 312-patient, double blind, randomized, placebo-controlled Phase III clinical trial of DCVax®-L for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. Based upon the PEI's approval, NW Bio will now proceed with the final administrative steps with the individual German hospital centers, in order for enrollment to begin.
"We are excited to receive this rapid final approval of our Phase III GBM trial from the German regulator," commented Linda Powers, CEO of NW Bio. "DCVax®-L is now one of the first active immune therapies to reach approval for Phase III trials by multiple major regulatory authorities. DCVax®-L is also now one of the first Advanced Therapy Medicinal Products (the legal classification covering all types of cell therapies in Europe) to reach Phase III clinical trials. We are now beginning the final phase of this important international Phase III trial, with enrollment in both Europe and the US occurring in parallel, potentially finishing enrollment by the late summer of next year, and potentially reaching top line results by the end of next year."
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 is also under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression, and some results expected before year end.. 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
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