Sept. 17, 2013
/PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing non-toxic DCVax
personalized immune therapies for solid tumor cancers, announced today 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.
NW Bio made its submission of the clinical trial documents with the three amendments included on
September 5, 2013
, and received the PEI's approval on
, 2013. The PEI approval letter stated that:
"The documents submitted have been assessed and deemed sufficient to fulfill the additional conditions imposed. As all legal requirements of Sections 40, 42 of the German Medicinal Products Act (AMG) are now complied with, the clinical trial can be started immediately." (English translation of German text).
This rapid regulatory response represents the last step in a long approval process before one of the most rigorous regulators in the world. It enables NW Bio to proceed with its Phase III trial in
, 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 NW Bio's international 312-patient, double blind, randomized, placebo-controlled Phase III clinical trial of DCVax®-L for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. Based upon the PEI's approval, NW Bio will now proceed with the final administrative steps with the individual German hospital centers, in order for enrollment to begin.
"We are excited to receive this rapid final approval of our Phase III GBM trial from the German regulator," commented
, CEO of NW Bio. "DCVax®-L is now one of the first active immune therapies to reach approval for Phase III trials by multiple major regulatory authorities. DCVax®-L is also now one of the first Advanced Therapy Medicinal Products (the legal classification covering all types of cell therapies in
) to reach Phase III clinical trials. We are now beginning the final phase of this important international Phase III trial, with enrollment in both
and the US occurring in parallel, potentially finishing enrollment by the late summer of next year, and potentially reaching top line results by the end of next year."
About Northwest Biotherapeutics