NEW YORK (GenomeWeb) – Tekmira Pharmaceuticals said this week that it has been notified that the US Food and Drug Administration has placed a hold on a Phase I study of the company's siRNA-based Ebola virus drug, TKM-Ebola.
According to Tekmira, the single ascending dose portion of the study, in which TKM-Ebola was administered to healthy volunteers without the use of steroid premedication to prevent immunostimulatory side effects.
"The FDA has requested additional data related to the mechanism of cytokine release, observed at higher doses, which we believe is well understood, and a protocol modification designed to ensure the safety of healthy volunteer subjects, before we proceed with the multiple ascending dose portion" of the study, Tekmira President and CEO Mark Murray said in a statement.
"We will continue our dialogue with the FDA, provided for under our fast track status, in order to advance the development of this important therapeutic agent," he added.