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Northwest BioTherapeutics, Inc. (NWBO) Advances Toward Commencement Of Phase III Brain Cancer Trial In Europe

|Includes: Northwest Biotherapeutics, Inc. (NWBO)

Today, Northwest Biotherapeutics announced that it has named a leading international contract research organization (CRO) to manage its 312-patient Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer in Europe - building on almost three years of manufacturing development, regulatory processes, and clinical preparations there.

Well underway in the United States, NW Bio's Phase III trial is currently enrolling at 41 sites. The U.S. trial is being managed by a U.S. CRO that does not have operations in Europe that can accommodate this trial. Having undergone considerable preparations and regulatory approvals in Europe, the trial is poised to begin enrolling patients later this calendar quarter in the U.K. and elsewhere in Europe in the next several months.

One of the last steps required for initiating enrollment in the U.K. was engaging a first-class CRO. Following an extensive RFP process, NW Bio chose PAREXEL International - a leading international CRO with unmatched expertise in managing international clinical trials. They have gained considerable expertise in oncology over the past 30 years, including glioblastoma. The CRO is headquartered in Boston, Mass., and operates in 71 locations with more than 14,000 employees throughout 54 countries worldwide.

The engagement to manage this Phase III brain cancer trial in Europe builds on the foundations of NW Bio's European programs that have been in development since 2010. Preparations completed by the company in the U.K. for the Phase III trial include: gaining regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA, equivalent to the FDA in the U.S); 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 Kings College Hospital, the lead site; and manufacturing technology transfer and validation in the U.K. In Germany, Phase III trial preparations completed by NW Bio include: establishing a wholly owned subsidiary (NW Bio GmbH) with a highly experienced CEO (formerly in the senior management of Schering A.G.); selecting 24 candidate trial sites, including all major opinion leader centers in brain cancer; a half-year of manufacturing technology transfer, followed by a two-year regulatory process for manufacturing certification by both the national and local regulators in Germany - further followed by developing a validated data package adequate to support Phase III trial designation; preparing and submitting the Phase III trial application package to the national regulator (or PEI); and initial preparations for Ethics Committee approvals 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," said NW Bio CEO Linda F. Powers. "After three years of extensive preparatory work, this is an important milestone and a reflection of the exciting potential of this trial. 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."

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