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

To: aknahow who wrote (14749)	9/19/2000 11:22:46 AM
From: manfredhasler	Respond to of 17367

George, Re: DSMB (data safety monitoring board) I agree. XOMA is the last to get preliminary study results. XOMA can have an input in the phase of the study design. And it is quite common that this influence is rather strong (the math of the numbers of patients to be enroled is done before study begin - and with that the calculation of the study costs). If nothing mandatory written in the study protocol, and no bold decision are taken, then XOMA has just to sit out the execution of the investigators and the DSMB. Did I blame XOMA in respect of the study execution? If I did I take it back. Regards, Manfred

To: aknahow who wrote (14749)	9/19/2000 6:32:10 PM
From: Cacaito	Respond to of 17367

"We also analysed mortality for patients who survived to receive complete infusion of study drug. Mortality among these patients was much lower in the rbpi21 group than in th placebo: 4 (22%) of 180 versus 12 (62%) of 195% (p = 0.07 ) As expected, most deaths occurred in patients with high GMSPS at baseline (rbpi21 13 high vs 1 low ; placebo 17 high versus 3 low)." This attempt still does not get the drug to showed but a good trend (albeit, I do accept the authors plead that "overall trends are consistent and most probably not due to chance, but due to actual drug effect" the last sentence not a direct quote. The early two arms division of the study was not used to analyse the data, except for the presentation of the high mortality in the high GMSPS (Glasgow...)

To: aknahow who wrote (14749)	9/19/2000 6:53:51 PM
From: Cacaito	Read Replies (2) \| Respond to of 17367

Overall an excellent study both in design an execution under the circumstances of big logistical problems like recruitment of patients in a disease that is rare, early use of the drug is imperative, rapidity of disease progression, informed consent, and the need for "slow infusion" of the drug. Maybe a one fast dose that is not eliminated fast in the body, or a fast dose at the local centers before reaching the major center then the infusion (baboons were pre treated if I remember well).