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

To: Biomaven who wrote (10758)	7/12/1999 11:14:00 PM
From: aknahow	Read Replies (1) \| Respond to 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.

To: Biomaven who wrote (10758)	7/12/1999 11:23:00 PM
From: Bluegreen	Respond to of 17367

Peter, first of all, thanks for the response. I am very happy to see a person of your caliber visiting this board. As I understand it in the beginning Xoma was adrift after the Biotech wars and probably wasn't too sure of etiology or precise mechanism of action of BPI. I am sure you know how Xoma acquired their portion of rights to BPI and subsequently more rights from INCY. Now enters a famous Pediatrician from the Dallas-Ft. Worth area by the name of Dr. Girior. He was familiar with BPI and convinced Xoma to do Phase I/II open label for Meningo. Once again as I understand it Dr. Girior was the force behind Meningo. trial. I am sure you have seen the Phase I/II results. Now back to your question, how and why did the good doctor want Meningo. try? When dealing with Meningo. the patients are usually in great shape health wise before calamity. Mainly healthy kids, nothing much to muck up a trial with endpoint of mortality in regard to sepsis. Now as time passed, action of BPI has been demonstrated by electron microscopy and of course the Baboon paper. Next at bat is the Hemo. Trauma trial which I am sure pleases you more along the lines of your question. One more time, most people don't understand the possible POTENT antibacterial effect of BPI on gram neg. bugs. The FDA finally came to Xoma, yes, THEY came to Xoma to discuss BPI as an anti-infective......the first time the FDA has come to anyone in regard to BPI possibly being an antibacterial agent. The worldwide collaborations on BPI are staggering....just look at Bob's 10,000 post on this thread. As you know it is a long shot at getting approval and what I have just posted could all be wrong. This is just how I understand things and only my opinions.

To: Biomaven who wrote (10758)	7/13/1999 7:22:00 AM
From: Robert K.	Read Replies (2) \| Respond to of 17367

I have NOT found this to be a reliable indicator, but there "appears" to have been a good bump in berlin. >http://money.berlinerboerse.de/cgi-bin/such.cgi?such=xoma Peter, good questions, excellent comments. Is not the meningo a antibiotic plus bpi trial. Ditto that for baboon trial. Ditto that for trauma. Ditto that for abdominal. Also did you see the amgen news today on IL-1. The fda allows NO phase 3 after 2 phase 2's. Interesting. Off topic, I still watch and wait on sepr. Rather than clutter the board, can you private mail me your thoughts on their future, timing etc. I value your opinion on sepr. Thanks if you do, and ok if you dont. All IMO standard K.