Wednesday, February 06, 2013 11:02:43 PM
Phase III GBM Brain Cancer Trial Currently Under Way
• 300-patient, randomized (2:1), double blind, placebo controlled Phase III trial: the “gold standard” in clinical trial design
• Primary endpoint: PFS (progression free survival) Endpoint will be satisfied by 6-month extension of PFS…. 1/3 of extension seen in Phase I/II trials
• Secondary endpoints include OS (overall survival) Trial is powered for OS as well as for PFS
• Crossover arm for patients who progress…. without un-blinding
• Treating patients who have newly diagnosed GBM
• 41 clinical trial sites across US; Additional US sites in process
• 30 sites pending in Europe: 6 UK sites; 24 German sites
• ~16-18 mos. to reach top line results (PFS primary endpoint of trial) with enrollment occurring at maximum sites
In Reply to 'a1derfullife'
See slide 12 of the linked presentation
NWBO Jan 2013 presentation
http://www.nwbio.com/pdf/NWBio_Corp_Overview_Summary_PowerPoint_Jan-2013.pdf
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