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Biotech / Medical : XOMA. Bull or Bear?
XOMA 26.37-8.4%Jan 16 9:30 AM EST
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To: aknahow who wrote (9969)5/14/1999 6:45:00 PM
From: xomadog2  Read Replies (3) of 17367
 
George-

There were many problems with the E 5 trial. The data was marginal at best, the endpoint for the trial was mortality.

At the same time as this trial was in its phase three and on the way to the advisory panel at the FDA, XOMA sued CNTO for patent infringement. Xoma eventually won, but CNTO did not make it to market with its compound. Meanwhile, the company and the FDA did not see eye to eye with regard to E5.

E5 was a monoclonal mouse antibody that was not popular with the FDA. At best it neutralized the endotoxic cascade. It did not kill bacteria. It was supposed to help sepsis patients because it neutralized the cascacde. The clinincal results were not able to attain clear beneficial results. The pvalue was greater than.05.

There was public pressure and political pressure in anattempt to win approval for this drug as well as have it blocked and killed. Pfizer was Xoma's partner. They were very involved with the approval process. The strategy did not work. Pfizer dropped the drug in the middle of another phase 3 of a larger sampling, 3 years later.

So, the fda did not like the drug,it was not a bacteria killer. BPI is a bacteria killer. E5 was a monoclonal mouse antibody. Not many people liked it. It was hard to show a clear benefit for sepsis
in using mortality as the endpoint.(if not impossible).
That is why among other reasons,BPI is being used in Menningococcemia
instead of SEPSIS. The FDA still wants to do a SEPSIS trial with BPI using mortality as the primary end point.
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