Stealth Peptides Inc. Announces Clinical Phase I Results With Bendavia(TM) Demonstrating Safety And Tolerability With Highly Predictable Pharmacokinetics
9/13/2010 9:28:17 AM
BOSTON--(BUSINESS WIRE)--Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies, announced today the results of its first–in–humans Phase I clinical trial of Bendavia™, a new chemical entity that targets mitochondria to treat ischemia reperfusion injury. This double–blind, placebo–controlled, randomized study evaluated healthy male and female volunteers representing a broad range of adult ages. During the study, volunteers received one of five ascending doses of Bendavia or placebo administered as an intravenous infusion over a four hour period. An independent Safety Review Board closely reviewed all of the safety data from the clinical trial and preliminary results demonstrate that Bendavia appears to be safe and well–tolerated at the doses evaluated, with no serious adverse events reported. Pharmacokinetic analysis from the study also showed highly predictable dose–proportional exposure of Bendavia over a span of plasma levels that included doses exceeding the expected patient dose by several fold.
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