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Biotech / Medical : XOMA. Bull or Bear?
XOMA 26.33-8.6%Jan 16 3:59 PM EST
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To: Biomaven who wrote (10758)7/12/1999 11:14:00 PM
From: aknahow  Read Replies (1) of 17367
 
Peter, I am not sure the Meningococcemia trial was as expensive as most. Or at the least, it was thought of as a relatively small trial of 200, with a clear major end point of death and a mortality target that would provide the statistical power. The trial ran to 395 but still seems smaller than most P III trials.

I do not know that this trial was cheaper and am simply positing that cost of the trial does not seem to be a weak point in the design. The only death in the P I/II trial with 26 subjects, was that of a 350 lb 18 year old. The dramatic results of this small unblinded trial led to the pivotal P III. So for a relatively small cost XOMA now has a completed P III.

XOMA says it has also experienced difficulty accruing subjects resistant to antibiotics for other trials and has looked at CF as one area that could provide better prospects for accrual of drug resistant subjects. If you simply put BPI up against another good, standard of care antibiotic it would seem you would have a heck of a task demonstrating statistical significance. The antibiotic works and BPI works, and while it may work very rapidly and with much more effectiveness, in a clinical trial you may need something like Meningococcemia to see this, or to test BPI against resistant bacteria.

BTW it was Dr. Brett Giroir, an outsider, who convinced XOMA to do the trial on mengingococcal septic subjects. I think conventional wisdom inside XOMA was originally against it.

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