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Replies to post #74050 on Biotech Values
Side Effects: Safety and tolerability endpoints were a major focus of the recently completed Phase 2 trial of LY450139. Three treatment discontinuations included a small bowel obstruction, hemoglobin-positive stool, and diarrhea. Drug- and dose-related QT prolongation occurred in the 140 mg/day treatment group. Other adverse effects included skin rashes and hair color change in treated patients. Somnolence, fatigue, and asthenia occurred in 10 LY450139-treated patients vs. two placebo patients. In a previous study of LY450139 two subjects were withdrawn from treatment in a 2-week tolerability study (Siemers et al., 2005). One subject withdrew from increased serum amylase and lipase concentrations, and exacerbation of previous gall bladder and biliary disease. The second patient experienced nausea, vomiting, weakness, and diarrhea accompanied by elevation in white blood cell count. In a second previous clinical test of LY450139 the incidence of gastrointestinal side effects in treated patients included six cases of diarrhea vs. zero in placebo group (n = 33-35 in each study group, p = 0.025), and esophageal failure that eventually led to death of a treated subject (Siemers et al., 2006). Elevated eosinophil counts were noted in LY450139-treated patients. The side effect profile of LY450139 in patients is consistent with a mechanistic cause, i.e., inhibition of γ-secretase substrate Notch.
08/17/10 11:13 AM
…the Lilly/Elan secretase inhibitors are destined to be interesting failures.
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