FDA confirms TKM Ebola trial now on partial hold - Tekmira Pharma

Tekmira Pharmaceuticals has announced that the FDA has verbally confirmed they have modified the full clinical hold placed on the TKM Ebola Investigational New Drug Application (IND) to a partial clinical hold. This action enables the potential use of TKM Ebola in individuals infected with Ebola virus. The Company remains on clinical hold as it relates to the multi-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM Ebola. The TKM Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study and involves single ascending doses and multiple ascending doses of TKM Ebola. The study is assessing the safety, tolerability and pharmacokinetics of administering TKM Ebola to healthy adult volunteers without administering any steroid pre-medications.