FDA OK's Potential Ebola Drug Use in Humans

Tekmira Pharmaceuticals announced that the FDA has given verbal confirmation regarding its modification of the full clinical hold on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold.

The FDA's decision allows the potential use of TKM-Ebola, an anti-Ebola virus RNAi agent, in patients infected with the Ebola virus. Tekmira still remains on clinical hold related to its multi-ascending dose portion of its Phase 1 study in healthy subjects with TKM-Ebola.

The Phase 1 clinical trial is a randomized, single-blind, placebo-controlled study that is comprised of single ascending doses and multiple ascending doses of TKM-Ebola. The study's aim is to evaluate the safety, tolerability, and pharmacokinetics of administering TKM-Ebola to healthy adults without administering any steroid pre-medications.

RELATED: Are Ebola Outbreak Fears Warranted? Experts Weigh In

Results from preclinical studies showed that when siRNA targeting the Ebola virus via Tekmira's LNP technology were used to treat previously infected non-human primates, there was 100% protection from an otherwise lethal dose of Zaire Ebola virus.

In March 2014, Tekmira was granted Fast Track designation from the FDA for the development of TKM-Ebola. The current research is being conducted under contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS).

For more information visit JPEOCBD.mil.

Loading links....