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Biotech / Medical : Cell Genesys (CEGE)
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To: Mike McFarland who wrote (1280)11/1/2004 11:54:17 AM
From: charlyt  Read Replies (1) of 1298
 
I agree, dull CC. I'm a shareholder and it's going to be a long wait for this one to play out.

VITAL-1 is vaccine by itself vs. Taxotere + prednisone in patients that do not have bone pain. Survival is the primary endpoint. Importantly they have a SPA from the FDA so a statistically significant improvement in survival should mean approval. Given the survival times in the phase 2 study, we may not see the complete data from this trial until 2007.

VITAL-2 is in patients that have prostate cancer which has metastasized to bone and is causing bone pain. In this study the treatment arms are vaccine + Taxotere vs. Taxotere alone. Reduction in bone pain is the primary endpoint with survival as a secondary endpoint.

I wonder if VITAL-2 won't finish first because these patients are sicker and the primary endpoint isn't survival.

The lung vaccine seems to be perpetually stuck in phase 2. Now that enrollment is almost complete what is the timing for phase 3? Given the survival data from the initial phase 2 trial reported in April 2003 it may be ASCO 2006 before we see the results of this phase 2 trial. Do they not start phase 3 until after that data is out? Probably despite the initial comments that it would start 6 months after the prostate vaccine went in to phase 3.
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