TKM-Ebola: Phase I ongoing

Tekmira said FDA converted the full clinical hold it had placed on a single-blind, placebo-controlled, U.S. Phase I trial of IV TKM-Ebola to a partial hold. The company said the action “enables the potential use” of the product in individuals infected with Ebola virus, but that it remains on clinical hold “as it relates to the multi-ascending dose portion” of the trial. FDA placed the full clinical hold last month on safety concerns after Tekmira completed the single ascending-dose portion of the trial (see BioCentury, July 21).

The single ascending-dose portion evaluated doses of 0.075-0.3 mg/kg in 19 healthy volunteers. Last month, Tekmira said 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 to ensure the safety of the volunteers before Tekmira begins the multiple ascending-dose portion, which plans to evaluate 0.06, 0.12 and 0.24 mg/kg TKM-Ebola in 12 volunteers. ...