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

To: Bluegreen who wrote (9338)	3/23/1999 12:26:00 PM
From: aknahow	Respond to of 17367

Bluegreen, this is an older FAQ. Questions from the 1997 Annual Meeting Who is the meningococcemia Phase III Data Safety Monitoring Board? What do they do? The DSMB is an independent body of medical experts, who are not XOMA employees but are chosen by XOMA with FDA guidance and are assigned the task of reviewing the data at increments during the study. They do not reveal the data to XOMA or other parties. What was the result of the meningococcemia DSMB meeting May 30, 1997? At the meeting, they decided certain administrative matters, ratified the size (200 patients) and design of the trial, announced increments for interim analyses (65 and 130 patients), and asked us to not disclose the number of deaths. What is an interim analysis? Interim analyses are a way to look for unexpected safety and efficacy issues. During the trial, the DSMB are the only people that are unblinded to the data (i.e. which patients received drug and which placebo). All they can report back to the company is that the study can continue, or that the study should be stopped early, because of an unexpected safety problem, or alternatively, unexpectedly higher efficacy than planned for that study. Studies are not designed to stop at an interim analysis, but virtually all double-blind placebo-controlled studies have interim analyses in case of the unexpected. When will the meningococcemia interim analysis take place? The first interim analysis will be in September 1997 covering the first 65 patients and including a 60-day follow-up period. An additional interim analysis is planned at 130 patients. Given the size of the trial and the historical mortality rate of the disease, investors should be cautious in terms of expectations from any interim analysis. Obviously the most important endpoint is survival. But equally important endpoints are the morbidity effects of meningococcemia. For example, what about limb amputation? Do we have data on that? The text of a detailed analysis of the Phase I/II study with historical comparisons and data about morbidities has been accepted by a major medical journal. We expect to see it published later in 1997. In the meanwhile, one of the clinical investigators presented that data last March in Munich at the 4th International Congress on Immune Consequences of Trauma, Shock & Sepsis. Her conclusion was that compared to historical patients, children treated with rBPI-21 (Neuprex(tm)) had not only improved survival but also improved overall outcome, as measured by the Pediatric Overall Performance Category Scale, which takes into account amputations, neurological damage, etc.