Northwest Biotherapeutics ($NWBO) completes significant milestones in DCVax-L program for brain cancer in Germany

Northwest Bioterapeutics (OTCBB: NWBO) joined the Fraunhofer IZI Institute in announcing that, working closely together over the course of more than 13 months, the parties have completed significant milestones in NW Bio's DCVax-L program for brain cancer in Germany.

• As a result, the company is poised to move forward in the near term in Germany with both its clinical trial program and Hospital Exemption cases under Section 4B of the German Drug Act
• A four-month long technology transfer of the manufacturing process for DCVax-L was carried out by NW Bio, its contract manufacturer, Cognate BioServices and Fraunhofer IZI. In addition, a multi-month process was completed to create the extensive documentation required to apply for manufacturing authorization in accordance with Section 13 of the German Drug Act (AMG), the application was submitted to the responsible pharmaceutical supervisory authority, and the 9-month long regulatory process has been completed up to the point of the official acceptance inspection.
• The parties are now awaiting that final inspection, which is the last step required before the manufacturing authorization can be granted and manufacturing can proceed for clinical trials and Hospital Exemption cases.
• The inspection is scheduled for June 2012.