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

To: franksja who wrote (12360)	12/1/1999 11:53:00 PM
From: Cacaito	Read Replies (1) \| Respond to of 17367

J of Trauma, April 1999, Pages 676-677, Editorial Comment: "A variety of substances have been proposed to favorably alter the outcome of the response to injury. some of them, such as prophylactic antibiotics for penetrating chest or abdominal trauma and methylprednisolone for spinal cord injury, have clearly been shown to be beneficial. The same cannot be said for the multiple cytokines and cytokine inhibitors that have been evaluated for sepsis and septic shock and for injured patients in what already is a highly select population of patients with a particular syndrome or illness who, after POST HOC analysis, are purported to be helped. There are hazards with the use of statistical tests when the hypothesis has not been proposed UNTIL AFTER the results have been analyzed." " Demetriades and colleagues have performed a difficult prospective, randomized, clinical trial of rBPI21 in seriously injured patients who were given 2 or more units of blood within 12 hours after injury. The median Injury Severity Score (ISS) for the 401 patients in this phase II evaluative study was more than 20. We can conclude, therefore, that this is a group of patients at risk for death and complications. There was no difference in mortality, serious infection, organ dysfunction, and days of ventilatory support or other measures of hospital resource utilization between patients who received rBPI21 and those who received placebo. ONLY ON POST HOC analysis was a difference between patient groups noted." " Previous studies have demonstrated that the duration of ventilation, an ISS equal or more than 16, a Glasgow Coma Scale score equal or less than 8, and blunt injury are risk for the development of postinjury pneumonia. In the study by Demetriades et al.,there is an 8% difference in the incidence of pneumonia between the patient groups, and this is significant only when coupled with acute respiratory distress syndrome, which has only 2% variability in occurrence. Linking parameters that alone are not statistically significant is problematic. Examination of the data provided also reveals that the lower proportion of patients with pneumonia and acute respiratory distress syndrome in the rBPI21 group occurred primarily among patients who had penetrating trauma. Additionally, more information is needed to determine their risk for this complication based on PREVIOUSLY defined parameters. Although the predisposing factors for pneumonia APPEAR to be similar between the placebo and treated groups, there is an important although perhaps not significant difference in ISS in these two populations. Thus, there may be a type II statistical error that accounts for this finding." "The authors have been honest in presenting the information in a forthright way in and have appropriately chosen to perform a phase III trial in an even more select group of injured patients to investigate a reformed hypothesis. Although it is laudable to search for the link that will improve patient outcomes after injury, one has to wonder how practical it will be to identify the highly select patient groups that rBPI21 and similar substances will benefit. The proposed study should provide that information." "Mark Malangoni, MD Department of Surgery MetroHealth Medical Center Cleveland, Ohio" end of editorial. My comments: 1. The reviewer clearly states several times the perils of xoma endeavors, the best he could come with was "it is laudable". 2. xoma must have had this type of comments by their own and independent reviewers and still ceoperson was SURPRISE of the pIII outcome. 3. the capitalized words are my emphasis, they did not appear originally in that way. 4. "chosen to perform a pIIIin an even more select group of injured patients" I read this more that 50 times, and now I noticed that pIII seems to be more selective, if this is the case I could understand ceo "surprise", but it is worse then since it was supposed to show the evidence easier in the selected subgroups, it speaks better of xoma and worse of Bpi (it was easier to blame xoma). 5. I still think trauma pIII must have being avoided and focused resources in other area or plain save money and avoid dilution. In the other hand, instead of having one option xoma was running two options (trauma and meningo)and spreading the risk, it just happen one option is gone, only one left for the immediate future,(the far future of xoma is of no interest to me if meningo fails). 6. xoma semi-silence is probably in the best interest of xoma, especially financing, but at the actual rhythm dilution will double the shares in the next 6 months, and the value of bpi is lower after failed pIII, forget the $32 from Sutro. Patient by default, cacaito (out of xoma, pending news).