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Biotech / Medical : Pharmos (PARS)

PARS 2.700

+13.6%

Jan 21 4:00 PM EST

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To: Clarksterh who wrote (1367)	12/20/2004 6:04:58 PM
From: NeuroInvestment	Read Replies (2) of 1386

I asked Gad Riesenfeld (maybe there was a breakdown in our English communication) today about differences in manufacturing--he stated that the new plant (did he mean process? It was my understanding that Pharmos had ramped up their manufacturing capacity in a facility that was going to require new cGMP inspection) was not yet approved, and that the dex was bioequivalent to what was used in PhII. But let's say that this was not the case. I do not remember the disparity between the two manufacturing methods, nor do I know the proportion of the HU210 enantiomer in each. But if the difference was 1%, that would mean that at most, there was 1.5mg more HU210 in the 'old' supply than the 'new.' Mechoulam's own work with HU210 as a neuroprotectant showed efficacy in rats at 45micrograms per kilogram--say the equivalent of 4.5 mg in humans (remarkably potent at that). Thus the hypothesis is that a HU-210 dose one-third the concentration used to show neuroprotection in rats accounted for the entire difference between the PhII and PhIII results in humans. I suppose it's not impossible, but it seems unlikely. Of course, no one's come up with a better explanation yet. Harry NeuroInvestment

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