Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: John Patterson who wrote (9074)	3/10/1999 2:08:00 PM
From: aknahow	Respond to of 17367

As always, I appreciate your post. As time goes on and the existence of the pre established mortality target has been stated by XOMA more than once, I must say I believe such a target was established. But at this point I don't think XOMA would ask for a change of endpoints. Mortality is a clear endpoint. Morbidity gets into the sticky area of trying to statistically prove which amputations were due to having lived rather than having died. XOMA knows a lower mortality rate by those in the trials potentially favors the Neuprex but they have a mandate to continue the trial until the mortality level is reached. I agree that all those seeing the patients and especially those tracking the endotoxin load know which ones got the drug, from the results they are seeing. The FAQ on this was carefully worded to produce a trueism. "No one knows who gets the placebo and who gets Neuprex" (My version of what they said). This is of course true, before the administration of the contents of the vials. The U.K. statistics on mortality are really not all that clear. I wonder if we will ever see data on mortality in the U.K. stratified to the Glasgow scale at time treatment began? Note that while 5% was given as the overall mortality rate, 50% was also stated as being the rate for more serious cases. It also would appear that the 5% was related to overall cases which may include meningitis as well as meningococcemia.

To: John Patterson who wrote (9074)	3/10/1999 2:16:00 PM
From: Cacaito	Read Replies (2) \| Respond to of 17367

Patients are adjusted by Glasgow Scale. If the overall mortality is lower then Bpi is working quite good. There is no evidence anywhere that patients adjusted by Glasgow Scale to be severely to gravely sick are doing better in England or anywhere else. Unless Xoma changed protocol to enter less severe cases, and there is no evidence of that either. Septic Shock from meningoccocemia is a swift killer. Patients on early antibiotics will must probably not be subjects of recruiment for Bpi trial. The fact that informed-consent is required delay Bpi treatment (not other treatments) and patients will be sicker due to that. Many has been dreaming on early termination. Many wants Xoma to publish more on the protocol (a lot is out, just go back on the thread). There would be no more data until the end of trial. The previous DSMB description (post by Robert S) could not be better to understand the length of trial. The Azt prevention trial in pregnancy was oustanding and they have couple of thousands subjects. Overwhelming data and still kept going. But giving up a little, less imagine that most of the recruits are of the less sick catergory (Glasgow 8 to 12 if I remember well) still the mortality will be high in that group (20% to 30%). The mortality in the Glasgow score above 12 is even higher, probably in the 40% to 60% range. Go back and check the Barcelona results (available in the thread), the treatment there is very similar to England and they did account for early antibiotics, as early as before having any sign of disease. Still there was 5% mortality in that group. It shows how of a killer the disease is. There are few disorders out there that physicians could start treatment so early and still get 5% mortality. Look at Angina pectoris (chest pain from lack of oxigen to parts of the heart muscles) mortality is 4% to 6% and nobody wants this disease nearby. Finally, if mortality is 10% in the placebo group we should expect the study to continue for the next 1 or 2 years if they could recruit some 800 to 1000 patients during that time.