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Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?

To: marin who wrote (1328)	12/1/2004 7:30:15 PM
From: Clarksterh	Read Replies (1) \| Respond to of 1386

Thanks - I think I've answered most of the obvious questions about the citicoline failure. I attribute it to: 1) Even in best case a smaller efficacy than Dex (probably due to the fact that the avg time to administration of agent was 12 hours and I suspect that by that time things are OBE - certainly I could find no animal study that indicates efficacy when administered that late.) 2) The citicoline Phase II actually utterly failed its primary endpoints and they had to 'find' a subgroup in which there was a 'significant' p value. In contrast Dex generally passed its primary endpoints. (although Pharmos did have to create a subgroup for the endpoint that the FDA eventually chose to enforce (GOS)) 3) ??? Something odd happened to the placebo group. They just did better than in the previous trials. But no one seems to know why. The biggest 'hole' that I am currently trying to plug is the preliminary data for the percent of patients with GOSE 7 or 8 at 6 months in the DEX TBI phase III is 26%. This is significantly lower than I would expect based upon the Phase II results. Either Pharmos is essentially enrolling only GCS4-6 (the average GOS 5 score for GCS4-6 in the phase II was almost exactly 26%) or either Dex or placebo is performing substantiallyworse than they did in Ph II. One possibility, but it seems non-credible, is that as you know mGCS is more diagnostic than the other components and they have added an enrollment criteria that says that to get in as a GCS 7 or 8 your mGCS has to be <5. It would certainly make for a sicker population even while continuing to cover GCS 7 and 8. (As you know I work by trying to find holes and then plug them. Even after I have already 'bought in'.) BTW - Do you know what the randomization is for the Ph III? I assume 50/50. Also, do you know what the average time to administration of Dex was in the Ph II (it isn't in their paper). Clark