NW Bio Takes Next Steps In Moving Forward With Its Phase III Brain Cancer Trial In Europe

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.

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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."

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