"2012 was a watershed year for NW Bio. Years of work quietly building our key programs reached critical mass," commented Linda F. Powers, CEO of NW Bio. "Our strong progress on so many fronts in 2012 has positioned us for further acceleration in 2013, and sharpened our leadership position in the immune therapy space."
Progress in Lead Program: Clinical Trial With DCVax-L for Brain CancerDuring 2012, the Company's ongoing trial with DCVax-L for Glioblastoma multiforme (GBM) brain cancer was upgraded to Phase III trial status in the US, and was also approved in the UK to proceed as a Phase III trial. The trial was expanded from 240 patients to 312 patients, and significant enhancements of the trial (including additional interim analyses) were added. The trial expanded from 25 US sites at year end 2011, to 42 sites operating in the US and nearly 30 sites selected and in varying stages in Europe at year end 2012.
In the UK, the Company launched its partnering with Kings College Hospital and Kings College London -- premiere opinion-leader institutions. Three other premiere sites were also selected and agreed to participate in the trial, including Queens Hospital in Birmingham, University College Hospital in London, and Addenbroke Hospital in Cambridge.
In Germany, 24 hospital centers across the country were selected and agreed to participate in the trial. The Company's partnership with the Fraunhofer Institute was expanded. A $5.5 million grant was awarded by the German government (one of the largest such grants ever awarded), providing matching funds for up to half of the Company's trial costs and manufacturing costs there, which the Company plans to start drawing upon in Q2 of 2013. In the fall, 10 leading hospital centers across Germany, including all of the key opinion leaders in brain cancer, applied to the German healthcare system for authorization of reimbursement for DCVax-L for GBM br
|SOURCE Northwest Biotherapeutics|
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