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.
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.