Northwest Biotherapeutics, a biotech company focused on developing immunotherapy products to treat cancers more effectively than current treatments, today made a joint announcement with the Fraunhofer IZI Institute that 13-month collaborative efforts have resulted in the completion of "significant milestones" in NW Bio's DCVax®-L program for brain cancer in Germany.
NW Bio said it is now positioned to soon advance with both its clinical trial program and hospital exemption cases under the compassionate use cases, per the German Drug Act.
"It has been a very intensive process for well over a year to complete these important milestones in Germany," Linda Powers, CEO of NW Bio stated in the press release. "We are grateful to have such a strong and close working relationship with our partner, Fraunhofer IZI, and to benefit from their extensive expertise with German and European regulatory requirements. We are also excited to now be poised to move forward in the near term with our clinical trial program and Hospital Exemption cases in Germany, with its population of nearly 85 million people."
NW Bio's contract manufacturer, Cognate BioServices, teamed with Fraunhofer IZI to carry out the four-month long technology transfer of the manufacturing process for DCVax®-L.
The milestones include the completion and filing of all necessary documentation and applications as part of the regulatory process; and the parties are now awaiting the final inspection 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.
For more information visit nwbio.com
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