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 d
ose 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.
