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10/30/06 8:49 AM

#1407 RE: Gametheory101 #1405

<The company wouldn't know which Provenge preparation was for a placebo arm participant or a Provenge arm participant. They would therefore measure CD54 in all prepared doses and ask for a new leukapheris from any failed batches.>

The expectation was not to see CD54 upregulation for placebos. However, it is likely that they would prepare a small sample to see if the collected blood did the right thing before freezing it for later manufacturing for the cross-over treatment. This would make sense since they are running a parallel phase-2 open trial to test the safety and effectiveness of the frozen blood. So yes, no information leak on asking patients to come back.

http://clinicaltrials.gov/ct/show/NCT00170066?order=2