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

To: aknahow who wrote (8220)	1/7/1999 3:30:00 PM
From: Cacaito	Respond to of 17367

george w, I have the full Jama article. The 907 patients showed the following percentages of mortality according to clinical forms: Shock type (the xoma trial type for low Glasgow score) 27.4% Non Shock type 2% Hemorraghic diathesis (xoma trial type could be low or high Glasgow (Gl) score)63.6% Non Hem- 3.3% Coma (low Gl score) 40.6% Non Coma (low Gl score) 3.5% Focal Neuro signs (low Gl score) 34.8% Non focal n signs 4.3% CLINICAL FORM according to shock/time of presentation and IST or interval of symptoms to treatment: Subacute (more than 24 hours without shock) 2.8% Acute (7 to 24 hours with shock) 3.6% Fulminant (low Gl score)43.8% This showed the two different conditions: meningitis-non shock type vs meningococcemia-shock type, and very well described in your previous reference from Pediatric site. Xoma trial low Glasgow score is the type that will provide the evidence and value of Bpi: Fulminant, shock, coma like, focal neuro signs, hemorrhagic diathesis group of patients. Mortality in this group ranges from 27.4% to 63.6%. Hemorrhagic diathesis type are the ones with mutilation sequelae (and higher mortality)if they survive. This is the group that provides the rational for the use of TPA (anticlots and profibrinolysis), Of course, if both work they could be good in combination. The non-shock type is the group with lower mortality ranges from 2% to 8.9% (males 5.2%, females 5.6%). If we go back to my previous calculations from the UK data we could see that we have several pieces of the puzzle. We have the total 2800, the total mortality 10% = 280, We have about the number of xoma trial patients, and % (3/4 = 75%) from the UK. We know from this data and other septic trials that the Shock-type is about 27% to 63.6%, and that the phase II Bpi trial (The Lancet) most patients did have hemorrhagic diathesis abnormalities ( I will review the Hem-dia munbers later). We need the number of shock type patients in the UK. We can extrapolate from the Spain-Jama study. And if possible the % of UK deaths in both groups (shock vs non shock), Again the SJ study showed some of this numbers. Then we can make a model of what the possibilities are for the xoma bpi trial (albeit not enough to put a good chunk of money on it). The Jama-Spanish study show the low glasgow type of patients as: (this is not mortality, this % of patients with clinical characteristics some of then overlap, but roughly the xoma trial patients are probably between the shock and fulminant types). LOW Glasgow Scores: shock 13.5%, (one could argue that most xoma trial patients will be in this group, that I previously calculated as 20%, I will use this lower number to use in the calculation model, unless we get more british data). fulminant 5.1% Hemorraghic 3.5% coma 5.1% Focal neuro 3.7% HIGH Glasgow: subacute 23.1% acute 71.8% Overall deaths 5.5% (this is way lower than the 10% from the UK). Explanation could be different type of case reporting: Spanish cases were proven by culture identification of meningococci in blood, CSF or both. English reporting definition ?. But whatever the UK definition the bulk of the patients are clearly non shock types. Once again the xoma's bpi trial design is very wise, especially when they decided to recruit two different sets of treatment groups before starting the bpi trial with the data from the phase II. We see the same judicious way in the design of the trauma data to showed a difference in pneumonia/ARDS prevention vs a less focus study, again with the data from the phase II in hand. A common mistake of companies is trying to get the numbers after the total set did not showed a difference, but a subset did (trying to salvage the stock dip like ABTI, and AMLN, but assuring being sent back for repeat studies by the FDA,(like IPIC's citicoline trial).