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Biotech / Medical : Elan Corporation, plc (ELN)

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To: Peter Goss who wrote (6238)	1/10/2005 2:12:57 AM
From: Harold Engstrom	Read Replies (1) of 10345

Peter Goss, the history here is that AAB-001 is a follow on to AN-1792. AN-1792 was a protein that evinced an antibody response that resulted in reduced beta amyloid plaques. For those trial partcipants that achieved what Elan considered to be the threshold antibody titer, beta amyloid plaques were cleared fully away. An independent research group in Germany claimed that the group of patients they followed actually saw cognitive improvement. There were 2 issues with AN-1792: firstly, a small percentage of trial participants experienced cerebral swelling, and secondly, only 20% of trial participants reached the threshold antibody level. Elan went back to the drawing board and has emerged with the antibody itself. Now, presumably, all patients will be dosed with a sufficiently high level of antibodies. There has been some talk of the PII trial potentially being treated as a pivotal trial - with an early filing being possible, a la Tysabri. But, if the trial is only 180 patients, then I can't see this being the case (especially given the safety issues with AN-1792 that only emerged late in PIII trials.)

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