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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (8215)	1/6/1999 3:00:00 PM
From: Cacaito	Read Replies (1) \| Respond to of 17367

Another Failure: Confirmatory platelet activating factor receptor antagonist trial in patients with severe Gram-negative bacterial sepsis : A phase III, randomized, double blind, placebo controlled, multicenter trial. This is from France, (not the same approach of ICOS acetylhydrolase degradation of PAF). The product name is PAFra BN 52021. Tested in 59 centers across Europe. Inclusion criteria were strict, previously a less define study showed a 12% reduction in Gram negative subgroup. Exclusion criteria: use of Steroids, and/or immunoglobulins. (One of the recent protocols from Germany using TPA, all the patients were given steroids and other plasma proteins. Interesting difference in design. Total patients 608, 300 on treatment arm, 308 placebo. Of course they were looking for even a 10% difference in mortality. For the ones expecting terrible things for Bpi mortality reduction possibilities, if bpi showed a 20% to 10% reduction this is a whooping 50% reduction in mortality, actual numbers are probably able to showed significance but increasing the number if they continue a good recruitment rate is quite appropriate. PAFra trial Mortality at 28 day follow up: Treatment 49%, Placebo 47%. Strict criteria Mortality: Treatment 44%, Placebo 50% (12% reduction and P=0.29. From: Critical Care Medicine (Journal of the Society of CCM) December 1998. Volume 26. Pags 1963-1971. From the same issue, pages 1927-1931, an excellent editorial reviewing many of 21 previous studies (all failures, including Synergen, Bayer, Inmunex, Knoll, Cortech, Upjohn, Ipsen and Hoffman) all burn in the pursuit of antisepsis shock treatment. Other failures not included Lipo, lisophyline, nitric oxide inhibitors, ABTI. Xoma not included yet. Will Sturza embrace a sepsis company ever?