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Northwest Biotherapeutics (NWBT) Takes Next Steps in Moving Forward With Its Phase III Brain Cancer Trial in Europe



2/15/2013 9:50:33 AM

BETHESDA, Md., Feb. 15, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that, building upon nearly three years of manufacturing development, regulatory processes and clinical preparations in Europe, the Company has named a leading international contract research organization (CRO) to manage the Company's 312-patient Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer in Europe.

(Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO)

The Company's Phase III trial is well under way in the U.S., currently enrolling at 41 sites. In the U.S., the trial is being managed by a U.S. CRO that does not have operations in Europe that can handle this trial.

The Company's Phase III trial has undergone extensive preparations and regulatory approvals in Europe. The trial is poised to begin enrolling patients in the U.K. later in this calendar quarter, and elsewhere in Europe in the next several months.

Engaging a first class CRO was one of the last steps required for initiating enrollment in the U.K. After an extensive RFP process, the Company selected PAREXEL International. PAREXEL is a leading international CRO with unparalleled expertise in managing international clinical trials. Over the past 30 years, they have developed significant expertise in oncology, including glioblastoma. Headquartered near Boston, Massachusetts, they operate in 71 locations throughout 54 countries around the world, and have over 14,000 employees.

This engagement to manage NW Bio's Phase III brain cancer trial in Europe builds upon the foundations of the Company's European programs which have been in development since 2010. In the U.K., preparations completed by the Company for the Phase III trial include regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA equivalent to the FDA), nationwide Ethics Committee approval (equivalent to Institutional Review Board approvals in the U.S.), selection and qualification of the first four trial sites (major opinion leader centers), institutional reviews and approvals at the lead site, Kings College Hospital, and manufacturing technology transfer and validation in the U.K.

In Germany, preparations for the Phase III trial completed by the Company include the establishment of a wholly owned subsidiary (NW Bio GmbH) with a highly experienced CEO formerly in the senior management of Schering A.G. for many years, as well as selection of 24 candidate trial sites (including all major opinion leader centers in brain cancer), half a year of manufacturing technology transfer followed by a 2-year regulatory process for manufacturing certification by both the national and local regulators in Germany, further followed by development of a validated data package sufficient to support Phase III trial designation, then preparation and submission of the Phase III clinical trial application package to the national regulator (the PEI), and initial preparations for Ethics Committee approvals (equivalent to IRB approvals in the U.S.) at trial sites.

"Putting in place a CRO of PAREXEL's caliber is one of the final building blocks for our Phase III trial in Europe. After 3 years of extensive preparatory work, this is an important milestone and a reflection of the exciting potential of this trial" commented Linda F. Powers, CEO of NW Bio. "We are fortunate to have a large number of marquee institutions as partners in Europe, including the Fraunhofer Institute, Kings College Hospital and Sarah Canon Research Institute, among others. PAREXEL's international reach and deep experience, including in clinical trials with GBM brain cancer, will be a great addition to the team."

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 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/II trials in multiple other cancers. The Company has also conducted a Phase I/II trial with DCVax® for metastatic ovarian cancer together with the University of Pennsylvania.

Disclaimer

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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