Tekmira Pharmaceuticals Corporation has dosed the first subject in a Phase 1 human clinical trial of TKM-Ebola, an anti-Ebola viral therapeutic that is being developed under a US$140 million contract with the U.S. Department of Defense.
Study to assess safety tolerability and pharmacokinetics of TKM-Ebola
The TKM-Ebola Phase 1 clinical trial is a randomized, single-blind, placebo-controlled study involving single ascending doses and multiple ascending doses of TKM-Ebola. The study will assess the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult subjects. Four subjects will be enrolled per cohort. There are four planned cohorts for a total of 16 subjects in the single dose arm, and three planned cohorts for a total of 12 subjects in the multiple dose arm of the trial. Each cohort will enroll three subjects who receive TKM-Ebola, and one who will receive placebo.
Promising results in non-human primates
Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP technology were used to treat previously infected non-human primates, the result was 100 per cent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010).
This work is being conducted under contract with the US Department of Defense’s (DoD) BioDefense Therapeutics (BD Tx), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. Tekmira’s collaboration with the JPM-MCS was modified and expanded in 2013 to include significant advances in LNP formulation technology since the initiation of the program in 2010.
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