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

To: manfredhasler who wrote (14747)	9/19/2000 10:51:21 AM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

Manfred you stated>>>>>>>>>So what? Let me ask the question again: was it necessary to continue the study, as it became obvious that too many patient (57 patients that died or that met criteria for imminent death before receiving the study drug) had to be excluded - due to logistic reasons? What kind of reaffirmation for a proper execution do you get out of the full report now that even more patients died within the study groups as your numbers suggest - due to logistic reasons? Would it not be mandatory for a careful monitored study to halt it at an early point and to make the proper readjustments of the study design? At the end, this study might have been just waste of money, and what irritates me much more, waste of time, and waste of a great opportunity.<<<<<<< YES YES YES!!!!!!!!!!!!!! You can go back over the years and see my posts where I stressed OVER AND OVER the Baboon study and need to give Neuprex IMMEDIATELY along with conventional antibiotics. ALSO the quicker you can mop up LPS the better. Xoma says the FDA had a hand in designing this trial but who cares who is to blame for the faulty design and its byproducts???? Neuprex was up against a handicap it couldn't overcome. In my opinion Xoma should of walked at the beginning or at least somewhere into the trial as you suggest. Manfred, are you and I the only ones that didn't give our lunch money to the school bully???<g>

To: manfredhasler who wrote (14747)	9/19/2000 11:02:18 AM
From: aknahow	Read Replies (3) \| Respond to of 17367

Manfred, you do know that the study was blinded, don't you? XOMA did not know in which groups the deaths had occurred nor other details. The DSMB saw a favorable trend and the FDA mandated necessary mortality target of 34 had not been reached so the study continued. I am not sure how halting in mid trial to make an adjustment works in a well regulated, FDA controlled system. Might work better under a system that used a bit of anarchy and common sense. Perhaps it would be better to wait until you read the entire article.

To: manfredhasler who wrote (14747)	9/19/2000 11:23:25 AM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

Manfred, go through this article with a fine toothed comb. Keep in mind what happens to the bacteria load at just 2 hrs.!!!!!!!!! You even have that significant word associated with it also!!! Meningo. Phase III is like loading the Wright brothers plane with lead and then sneering that it can't get off the ground in my opinion. >>>>>>>Ann Surg 1999 Feb;229(2):262-71 Protective effect of bactericidal/permeability-increasing protein (rBPI21) in baboon sepsis is related to its antibacterial, not antiendotoxin, properties. Schlag G, Redl H, Davies J, Scannon P Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, Vienna, Austria. OBJECTIVE AND SUMMARY BACKGROUND DATA: The recombinant fragment of bactericidal/permeability-increasing protein, rBPI21, has potent bactericidal activity against gram-negative bacteria as well as antiendotoxin (lipopolysaccharide [LPS]) action. On the basis of these activities, the authors sought to discover whether rBPI21 would be protective in baboons with live Escherichia coli-induced sepsis and whether the potential protective effects of rBPI21 (together with antibiotics) would be more closely related to its antibacterial or LPS-neutralizing effects. METHODS: In a prospective, randomized, placebo-controlled subchronic laboratory study, the efficacy of rBPI21 or placebo was studied over 72 hours in chronically instrumented male baboons infused with live E. coli under antibiotic therapy. RESULTS: Intravenous rBPI21 attenuated sepsis-related organ failure and increased survival significantly. Bacteremia was significantly reduced in the rBPI21 group at 2 hours after the start of the E. coli infusion, whereas circulating LPS was less affected. The in vivo formation of tumor necrosis factor was significantly suppressed by the rBPI21 treatment regimen. Microcirculation and organ function were improved. CONCLUSIONS: In baboon live E. coli sepsis, the salutary effect of rBPI21 results from a more prevalent antibacterial than antiendotoxin activity.<<<<<<<<<