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

To: schadenfreude who wrote (9975)	5/14/1999 8:02:00 PM
From: Cacaito	Read Replies (4) \| Respond to of 17367

Otaku, meningococcemia = sepsis, the trial is a good strategy, it is a very clearcut model of sepsis. Pro: the meningo/children population is almost free of potential confounding complicating factors, very different to other models of sepsis. Con: slow recruitment due to the low incidence of the disease. The phase II on abdominal infections trial(not placebo control) showed very good results in a SEPSIS model. The phase IIhemorrhagic/trauma trial showed very good prevention of gram negative pneumonia (the main causes of sepsis are gram negative bacteria) and this is the intended use of Bpi. The trial did not show anything else of value (a trend to improvement, but FDA does not swallow trends). The Phase III is ongoing and smartly designed to decrease the composite pneumonia/ards, it is worthwhile if they get good results. But, they will need several thousands of patients to prove significant less mortality. But even if just proven to decrease pneumonia it will be used by physicians, if BPI is fda approved at the end of trauma trial. The initial phase I data on cystic fibrosis is a SEPSIS/but not shock model against one of the worst bacteria in hospital settings: Pseudomonas, both in vitro data and preliminary clinical data is showing good results. As opposed to the meningo trial, the hem/trauma trial is so full of confounding complicating factors that the exclusion criteria takes about one full page of data. If it were not for that they could recruit about 10 times faster, to their credit recruitment is going very fast (about 800, and they need like 3,000 in my view). E5 does kill bacteria with the help of the activated complement cascade. It does not prevent the inflamatory cascade and that was the problem in the septic shock trial (both for xoma and centocor). What is needed is not another killer of bacteria (there are many and many more are coming)but an inflammatory regulator. BPI is unique (so far) in be good doing both and that is the big value of it. Once Bpi is on the market for meningococcemia, many clinicians will rush to organize trial (with or without Xoma)cause is a good way to put one name in an academic prestigious paper. It will accelerate the development of the drug. Just look at the many trials of Viagra without Pfizer sponsorship. Just wait for 3 more months for unblinding, 2 months for NDA (if Xoma is well organized, if not add 2-3 more months) and 6 more months for FDA fast track decision, then ready to market (if manufacturing plants are ready and marketing partner is ready). Just 2 more years to make money (if approved).