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Biotech / Medical : Biotech Valuation

CRSP 57.05

-0.6%

Dec 9 3:59 PM EST

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To: former_pgs who wrote (20069)	5/18/2006 1:37:40 PM
From: Biomaven	Read Replies (2) of 52153

very likely a negative development Why is that? Their words were: expedited interim analysis of overall survival data* from the SPARC trial.* So apparently it's not safety data but survival data that they want to look at. From earlier this year: GPC Biotech cleared to continue prostate cancer trial 27th April 2006 By Helen Marshall An independent data monitoring board has recommended that GPC Biotech's phase III registrational prostate cancer trial, SPARC, continue through to completion as planned. Advertisement The data monitoring board (DMB) analyzed the efficacy data as assessed by the blinded independent progression review panel on the first 354 progression-free survival (PFS) events and also reviewed the safety data from the first 593 patients who had been randomized in the trial and had completed at least one cycle of satraplatin treatment. After reviewing the data, the DMB reported that the design and conduct of the trial remained sound. In addition, the DMB determined that the SPARC trial had also passed the pre-defined futility analysis. So after looking at a fair bit of data, the trial passed the pre-defined futility analysis. That means that worst case the drug at that point in time was only a little worse than the comparator. So what can have changed to make them want to take an expedited look, meaning they are now seriously considering halting the trial? That means they think there is a fair chance that they can now determine either that the drug is manifestly inferior or that it is manifestly superior (or that some safety issue has emerged, which seems unlikely). I would argue that "manifestly inferior" is unlikely in the context of the successful recent futility analysis. Peter

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