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

To: gfp927z who wrote (1335)	12/2/2004 2:55:12 PM
From: Clarksterh	Read Replies (1) \| Respond to of 1386

gfp - The CT info was from the 10-14-04 Bio Emerging Co Forum Conference. They said that in addition to the other improvements they made in designing the Phase 3, the CT scans had also been enhanced to help ensure that they were only enrolling the most severe patients - those with more frontal lobe damage (the patients most likely to benefit from the drug). Thanks. I knew I had heard/seen something, but couldn't remember what and where. 2) In the Phase 2, there were 39 GCS 7-8 patients enrolled (less brain trauma), and only 28 GCS 4-6 patients enrolled (more brain trauma). So only 42% of the patients enrolled in Phase 2 were of the type expected to show the best drug effect. The Phase 3 should have a comparatively higher % of high trauma patients (the Phase 3 mean GCS score was approx 3.8 vrs 4.21 for the Phase 2). Having more high trauma patients in the Phase 3 should mean even more drug effect than the Phase 2. I did the same calculations, but someone on the yahoo board correctly pointed out that I should be using the entire cohort, not just the retrospectively culled data that was published. On balance I agree - although of course less data is available. That data that is available is in their press release of that time. See: Message 14467325 I never entirely trust retrospective culling - especially if the cause for the culling isn't made crystal clear. 1/3 of the Dex patients were underdosed in the Phase 2. Of the 30 patients receiving Dex in Phase 2, 10 of them were dosed at only 48 mg (the other 20 patients at 150 mg). In contrast, all the patients in the Phase 3 got the higher 150 mg dose. This uniformly higher dosing in Phase 3 should translate into even better results. I'd agree, but Pharmos says in their published paper "dexanabinol treatment effects were not different between the two doses (data not shown)." Clark