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NW Bio Takes Next Steps In Moving Forward With Its Phase III Brain Cancer Trial In Europe
Date:2/15/2013

p>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
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SOURCE Northwest Biotherapeutics
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