Tekmira doses first subject in human clinical trial of TKM-Ebola
Tekmira Pharmaceuticals Corporation said on Tuesday that the first subject in a Phase 1 human clinical trial of TKM-Ebola, an anti-Ebola viral therapeutic, has been dosed.
The treatment is being developed under a $140 million contract with the U.S. Department of Defense.
"We are pleased to announce the first subject has been dosed in a Phase I clinical trial evaluating the safety of a new LNP formulation for our TKM-Ebola therapeutic," Tekmira President and CEO Mark Murray said. "Building upon our compelling preclinical results, the Phase I data generated will guide our determination of the appropriate dose of this drug for the potential use as a medical countermeasure against this lethal hemorrhagic fever virus. We remain on track to have data from this trial available in the second half of this year."
Murray said the company is well placed to develop future RNAi-based anti-viral therapeutics.
The clinical trial is a randomized, single blind, placebo-controlled study. It will explore the safety, tolerability and pharmacokinetics of giving the treatment to healthy adults.
Four people will be enrolled in each cohort of the study. Three people per cohort will receive treatment and one will receive a placebo. There are seven total cohorts planned.
Earlier studies were conducted on previously infected non-human primates, which resulted in 100 percent protection.