Partial clinical hold on Tekmira's Ebola therapy modified by FDA

Hepatitis B specialist Tekmira (Nasdaq: TKMR) says that the US Food and Drug Administration has modified the partial clinical hold on the company’s Investigational New Drug application for TKM-Ebola to permit repeat dosing of healthy volunteers.

The IND remains on partial clinical hold with regard to doses above 0.24mg/kg/day in healthy volunteers, but Tekmira will proceed with trials at a dose of 0.24mg/kg/day. The study is a randomized, single-blind, placebo-controlled study with repeat dosing of a single cohort of healthy volunteers where each subject will receive daily doses of 0.24mg/kg of TKM-Ebola or placebo for up to seven days. It will be administered without steroid pre-medication. Results from the study are expected in the second half of 2015.

Tekmira received notice from the FDA in July 2014 placing TKM-Ebola IND on clinical hold until additional information was provided and the multiple ascending dose portion of the trial protocol was modified to ensure the safety of healthy volunteers.