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

To: aknahow who wrote (9969)	5/14/1999 3:26:00 PM
From: PrometheusTex	Read Replies (3) \| Respond to of 17367

Good afternoon, The recent movement in volume and price has me back and paying attention to XOMA, and I finally decided to acquire better season tickets. The seats over at Yahoo were getting rowdy. My take from the scientists that I know who follow XOMA is that they are more concerned about the FDA than the drug itself. And they do point to E5 as an example of FDA difficulties >> drug difficulties. However, in this area I am quick to point out that I was not around for that fun. About the pink thing, it is my understanding that at least some significant part of the present range of applications/patents comes directly from the observations by the docs in phase II. (It is difficult for in-house biotech scientists to make the most important observations in a trial.) This change was so obvious, the Phase II docs find it hard to believe anyone could miss it. So listen for leaks now that the trial is finished. I personally will be surprised if there are none. Hope you don't mind me crashing the party. I will, as George once suggested to me over at Yahoo, try to stick to the science. I did vote no, BTW. ProTex

To: aknahow who wrote (9969)	5/14/1999 6:45:00 PM
From: xomadog2	Read Replies (3) \| Respond to 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.