Progress in DCVax-Direct ProgramThe Company announced its unusually broad Phase I/II clinical trial approved by FDA for DCVax-Direct for all solid tumor cancers. The Company initiated manufacturing arrangements for this trial in 2012. The manufacturing involves novel, patented processes for partial maturation of the dendritic cells comprising the active agent of DCVax-Direct, and novel automation with proprietary machines and systems.
The Company also entered into a Letter of Intent with Sarah Cannon Research Institute to partner in the execution of the Phase I/II trial in the US and UK. Sarah Cannon has a network of 700 oncology doctors, who see 75,000 new cancer patients per year in the US and UK.
Progress in ManufacturingDue to levels of manufacturing demand significantly higher than originally projected for the Phase III brain cancer trial, the Company arranged for doubling of the manufacturing capacity dedicated to production of DCVax-L in the US. The Company's contract manufacturer, Cognate BioServices, Inc. (Cognate) undertook the necessary construction for this doubling of capacity.
In Europe, the Company, its partner the Fraunhofer Institute, and Cognate completed the extensive regulatory processes and the final inspections for regulatory approval and certification for the manufacture of DCVax-L for the clinical trial in Germany – processes totaling more than 1-1/2 years of work. The Company, Fraunhofer, Cognate and Kings College also began the 7-month processes for regulatory approvals and institutional approvals in both the UK and Germany to enable the manufacturing in Germany to supply DCVax-L for the clinical trial in the UK as well. This German supply arrangement is in addition to the manufacturing under development in the UK. Having two manufacturing lo
|SOURCE Northwest Biotherapeutics|
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