SB Pulls Studies Of Cortech's Bradycor
SmithKline Beecham has suspended all human clinical trials of Cortech's bradykinin antagonist Bradycor (SB-238592), for the treatment of traumatic brain injury, in response to what Cortech describes as "anomalous" results from a small pharmacokinetic study in rats in which an unexplained mortality was seen in the test animals.
SB notified the clinical investigators of the human trials after finding the result, directing them to suspend all the trials pending clarification of the situation.
Cortech maintains that investigations to date strongly suggest that the results of the pharmacokinetic rat study "were due to a technical issue in the preparation or administration of the dosing solutions rather than an effect of the drug substance itself."
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