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RxTrials Institute Drug Pipeline Alert
July 30, 2008 | Vol. 6 No. 31
Valens Reports Mixed Results in Voluntary Phase II Trial
Preliminary findings from Valens Pharma’s voluntary Phase II trial evaluating its IV formulation of dichloroacetate in high-risk, geriatric patients undergoing open heart surgical procedures yielded mixed results.
The randomized, double-blind, placebo-controlled study in 83 subjects failed to demonstrate efficacy for the drug as measured by reduced time in an intensive care unit. However, biochemical benefits of the drug shown in earlier trials, such as lower plasma lactate levels and stable glucose levels, were confirmed, Valens said.
Although the company had approval from the FDA and Health Canada to conduct a Phase III trial, it chose to conduct a smaller, less expensive voluntary trial to assess certain clinical endpoints in the same high-risk geriatric population as its Phase III protocol.
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