German Regulator Oks Northwest Biotherapeutics' Late-stage GBM Trial To Open

(RTTNews) - Northwest Biotherapeutics (NWBO) announced 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.

The company said it 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 company noted that the authentication enables it 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 the company's international 312-patient, double blind, randomized, placebo-controlled Phase III clinical trial of DCVax-L for Glioblastoma multiforme or GBM, the most lethal form of brain cancer.

The company stated that it will now proceed with the final administrative steps with the individual German hospital centers, in order for enrollment to begin.