After 13 Months of Complex Processes, DCVax-L Program Poised To Proceed In Germany
- Category: Vaccines
- Published on Thursday, 26 April 2012 21:07
- Hits: 383
BETHESDA, MD, USA I April 24, 2012 I Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO) (NW Bio) 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 (i.e., compassionate use cases).
The English version of the Fraunhofer IZI Institute's announcement of Friday, April 20, 2012, can be found on the Institute's website at http://www.izi.fraunhofer.de/presseinformationen-lang.html?&L=1&tx_ttnews[tt_news]=107&cHash=fe82c5d8fafed440aa6d2269bdd7b5ea
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.
The completions of these processes constitute significant milestones. The processes included translating existing documentation into German, drafting SOPs (standard operating procedures) and documentation to meet European requirements, validating every source of reagents and supplies as GMP (clinical grade) acceptable under European standards and obtaining new GMP sources in Europe, conducting extensive training of German teams both in Germany and in the US, establishing and validating specialized shipping arrangements and documentation in Germany, conducting trial shipments, performing process validations according to Annex 15 of the EU Guidelines to Good Manufacturing Practice, performing validations of analytical methods according to the European Pharmacopoeia or ICH Guideline Q2A/Q2B and numerous other steps and processes.
"It has been a very intensive process for well over a year to complete these important milestones in Germany," commented Linda Powers, CEO of NW Bio. "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."
About Northwest Biotherapeutics, Inc.
Northwest Biotherapeutics, Inc. is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company is developing dendritic cell-based vaccines. The Company's lead clinical trial is a 240-patient trial in newly diagnosed Glioblastoma multiforme ("GBM"), the most aggressive and lethal form of brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has also conducted a Phase I/II trial with DCVax®-L for recurrent metastatic ovarian cancer. For further information about clinical sites and about the Company, please visit the Company's web site at www.nwbio.com.
SOURCE: Northwest Biotherapeutics