US regulators have lifted the clinical hold on Tekmira’s Ebola vaccine to allow for repeat dosing in healthy volunteers.
In July last year the US Food and Drug Administration placed TKM-Ebola 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.
This was subsequently modified in August to a partial clinical hold to allow the administration of TKM-Ebola to patients with a suspected or confirmed Ebola virus infection.
The firm has now confirmed that it plans to resume the randomised, single-blind, placebo-controlled Phase I trial in the coming weeks to re-dose healthy volunteers, and that results are expected in the second half of this year.
The anti-Ebola virus RNAi therapeutic is being developed under a $140-million contract with the US Department of Defence.