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Jul 21, 2014
 |  BC Week In Review  |  Clinical News  |  Clinical Status

TKM-Ebola: Phase I hold

Tekmira said FDA placed a full clinical hold on a single-blind, placebo-controlled, U.S. Phase I trial of IV TKM-Ebola after the company completed the single ascending-dose portion of the trial, which evaluated doses of 0.075-0.3 mg/kg in 19 healthy volunteers. According to the company, FDA requested additional data related to the mechanism of cytokine release that was observed in a single volunteer at higher doses and a protocol modification...

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