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

To: Robert K. who wrote (4932)	11/29/1997 1:29:00 PM
From: aknahow	Read Replies (2) \| Respond to of 17367

Bob, thanks. Wonder if this will generate a response from Giroir or additional details. I thought XOMA claimed the non mortality outcomes were also better. Wonder about the historical incidence of amputations in meningococcemia. Believe this response by Duncan (?) proves the need for XOMA to provide as great amount of info as possible to keep shareholders from being blindsided. Also demonstrates that it might have been good to involve the Aussies in P III for more than jut inclusion of Southern Hemisphere. P III seould be near 135 level. We know BPI does not make patients sicker. It may not cure them all but it would seem to be having some positve effect. And DSMB should be meeting soon, (my guess). Negative side of letter is that it gives more info than the original abstract and that fence siters now have a real reason to wait before committing to XOMA. Even so people like Sturza analyst were reading the whole origal article not just the abstract so they were aware of the 7 amputations. If BPI works really well the success will be even more spectacular given the doubts. Since P III trial has not been halted I do not believe results are much more favorabale than expected. But do think they probably are positive.

To: Robert K. who wrote (4932)	11/29/1997 2:15:00 PM
From: aknahow	Respond to of 17367

Bob, the protein C haemodialfiltration article provides some data on amputation. In prior studies subjects treated with just C incurred 50% and with just haemodiafiltration 75% amputations. (IF I HAVE READ INFO CORRECTLY) The co that supplied the protein C is Immuno A.G. Studies on Protein C alone were done in 1995 also.

To: Robert K. who wrote (4932)	11/29/1997 3:05:00 PM
From: aknahow	Read Replies (2) \| Respond to of 17367

Bob, on Dutch site interesting project on Rapid detection of Neisseria meningitidis (used for search as meningoccemia apparently is U.S. term) and Staph Aureus. using DNA probes. Project leader is Varaldo. URL too long to bring here.

To: Robert K. who wrote (4932)	11/29/1997 10:22:00 PM
From: Cacaito	Respond to of 17367

Xoma never claim any adventurous conclusion like that. It is clear that the study is small and that is the reason of the ongoing type III study. Xoma use the GMSPS scoring system to evaluate both the patients and the historical controls, and they came out with a reasonable number from the historical data (30%, or eight would have die instead of one). The GMSPS scoring system references are given in the article, one from The Lancet 1987, and another from a 10 year survey published in Critical Care Med 1991, 1992. I will check them, but it is not as important right now, in the meantime I will take it as face value. There is another outcome predictor based on "coagulopathy" or blood clotting problems for prognosis and it was use in the study. And there was a "marker of inflamation" (apparently designed by Xoma, and it showed above normal and very high levels of inflamatory molecules: LPS, TNF and IL-6. It is true that the inflamatory cascade was already trigger, but in my view it just showed BPI abilities to interrrupt the process. In regular clinical settings (without BPI)physicians are just praying that the "shock chain" stop, and just plain wait to see if the patient itself gets better. And they use the POPCS (pediatric overall performance category scale)use in Pediatric ICUs for outcome evaluation. It is a very well presented article and very conservative in their discussion.

To: Robert K. who wrote (4932)	11/29/1997 10:42:00 PM
From: Cacaito	Respond to of 17367

I have the print version of the article and the Inclusion Criteria said that BPI should be started no longer than 8 hours after the first dose of antibiotics. The average time of 5.7 hours after antibiotics, and 3.1 hours after admission to the Peds ICUl. I will prefer to start earlier, but imagine that you are explaining to the parents of a child that their child is very sick (just few hours before the child was perfectly fine or just with a small fever) 30% to 50% chances of dying and the survival means disability (amputations, brain damage...) and then one says: Please sign this investigational drug informed-consent, with three pages of legal words. First reaction is almost always " my child is not a guinea pig". How much time to start earlier? I am amazed that the investigators were able to get the parents to cooperate in less than the 8 hours that they plan for. For the type III study they could tell the parents about the previous type II study, but this time they have to also tell them that their child could received placebo, just salty water instead of the wonder drug. It is again very difficult to go ahead. Again, it is impressive that the results are so good even after several hours of the diagnosis. Maybe they could try to start the patients in the Emergency room, but again the logistics will be completely different.