By: Adam Feuerstein | 03/29/14 - 11:33 AM EDT
(NWBO) takes umbrage at anyone who describes the German Hospital Exemption decision for its brain cancer vaccine DCVax as "compassionate use."
"There are some commentators who have either misunderstood or mis-represented what we achieved and what I just described to you," said Northwest Bio CEO Linda Powers, speaking at a conference Wednesday. "Some commentators have said this [German Hospital Exemption] is just the same as compassionate use. That just reflects a complete lack of knowledge of the European system."
Northwest Biotherapeutics announced today that it is partnering with Fraunhofer for production of DCVax-L for brain cancer, for clinical trials and compassionate use cases in Europe...
The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in Leipzig, Germany, has dedicated a substantial portion of its state of the art manufacturing facilities to the production of DCVax®, and is assisting NWBT with the applicable regulatory requirements for both clinical trials and compassionate use cases. The Fraunhofer IZI is also selecting and initiating connections with leading clinical centers on behalf of NWBT and its DCVax products.
Northwest Biotherapeutics, Inc. today announced that, working together with the Fraunhofer Institute (IZI), it has received approval of a major grant from the Sachsische Aufbau Bank (SAB or Saxony Development Bank) in Germany. The grant will reimburse fifty percent (50%) of the costs for manufacturing in Germany and for NW Bio's clinical trial with DCVax-L for brain cancer at up to 30 clinical sites in Germany... As noted last week, following recent completion of 13 months of technology transfer and regulatory processes for certification of DCVax-L manufacturing in Germany, the final regulatory inspection of Fraunhofer IZI's manufacturing facility is scheduled for June. After the final inspection is successfully completed, manufacturing for the DCVax-L clinical trial and for Hospital Exemption cases under §4b of the German Drug Act (i.e., compassionate use cases) will be ready to begin.
We believe that our approach of conducting a Phase III clinical trial of DCVax-L in GBM at 80 or more sites on both sides of the Atlantic, at some of the best medical research institutions in the US, UK and Germany, is unique in giving the Company two chances at product approval in the two largest medical markets in the world: the United States and Europe. We have worked for nearly one and a half years to establish these institutional relationships, and pursue the necessary regulatory and institutional approvals. We are now positioned to reap the benefits of this two-continent strategy. In parallel with our clinical trial program, we are undertaking compassionate use programs in both the United Kingdom and Germany. In the United Kingdom, this program will proceed under the "Specials" category. In Germany, this program will proceed under the "Hospital Exemption" provided in §4b of the German Drug Act. Both Kings College London and Fraunhofer will manufacture product for these compassionate use cases. In these cases, patients who are not eligible for the clinical trial can obtain DCVax. Such cases are not covered by insurance: the patients pay for the product on a self-pay basis.
Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, announced today that the Company has taken a key step in building Europe-wide arrangements for manufacturing and distribution of DCVax. This represents a major area of competitive differentiation and strength for NW Bio. The Company and its partners have completed a 7-month process of obtaining the necessary regulatory and institutional approvals in both Germany and the U.K. to expand the scope of the manufacturing in Germany of the Company's DCVax-L product for brain cancer... In regard to the product categories, these approvals will enable DCVax-L to be produced in Germany not only for the Phase III clinical trial, but also for Hospital Exemption cases under Section 4b of the German Drug law (similar to compassionate use in the U.S.)
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