JPM-MCS starts human clinical trial for Ebola therapeutic

The U.S. Department of Defense's Joint Project Manager Medical Countermeasure Systems announced on Monday that the first subject was dosed in a Phase I clinical trial of an anti-Ebola therapeutic.

JPM-MCS BioDefense Therapeutics, also known as MCS-BDTX, is developing the TKM-Ebola therapeutic through a contract with Tekmira Pharmaceuticals Corporation. The Phase I trial will test the pharmacokinetics, tolerability and safety of TKM-Ebola to determine the proper dosage of the drug as a medical countermeasure against Zaire Ebola virus.

JPM-MCS said the Zaire Ebola virus is one of the most deadly hemorrhagic fever viruses.

"Currently there are no available vaccines or therapeutics to prevent or treat the Ebola virus," Lt. Col. Eric Midboe, the joint product manager for MSC-BDTX, said. "This Phase I trial represents an important step in our effort to provide (U.S. Food and Drug Administration)-approved therapeutics targeting the deadly hemorrhagic fever viruses. This work complements the efforts of other acquisition programs within the (DoD) medical countermeasures portfolio that includes diagnostic systems and vaccines to protect DoD personnel and the nation."

In preclinical studies published in the Lancet in May 2010, TKM-Ebola demonstrated efficacy when the drug was delivered to infected non-human primates. The drug provided 100 percent protection from an otherwise lethal dose of Zaire Ebola virus.

"We are pleased with Tekmira's progress and the first dosing of the new formulation of TKM-Ebola in the Phase I human clinical trial," Adekunle Famodu, the MCS-BDTX assistant product manager overseeing TKM-Ebola's development, said. "The trial will provide important safety data required for the next phase of development of this innovative solution to counter one of the most lethal hemorrhagic fever viruses."

The JPM-MCS, which is a component of the Joint Program Executive Office for Chemical and Biological Defense, seeks to provide the U.S. and its military forces with innovative, safe and effective medical countermeasures for biological, chemical, radiological and nuclear threats.