Tekmira gets fast track designation for anti-Ebola therapeutic
The fast track designation for TKM-Ebola is meant to facilitate the development and expedite the review of the drug. The FDA gives the designation to drugs that treat serious conditions and fill an unmet medical need with the purpose of getting new drugs to patients earlier.
"This is an important milestone for Tekmira and our TKM-Ebola program," Mark Murray, the president and CEO of Tekmira, said. "Receiving a fast track designation from the FDA supports our work to advance the development of this therapeutic as quickly as possible. Our leadership in developing anti-viral therapies has been supported by our collaboration with the U.S. Department of Defense, which is funding the development of TKM-Ebola."
Murray said the company dosed the first subject in a Phase I clinical trial of TKM-Ebola in January. The trial is evaluating the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult subjects. Tekmira seeks to have data from the trial available in the second half of 2014.
Tekmira is developing TKM-Ebola under a $140 million contract with the DoD's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office.