The Food and Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on Tekmira Pharmaceutical’s TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold, according to a company press release Thursday.
This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.
“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so,” said Dr. Mark Murray, CEO and President, Tekmira Pharmaceuticals.Â “This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognize the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols.”
As of 4 August 2014, the cumulative number of cases attributed to Ebola Virus Disease in the four countries stands at 1,711, including 932 deaths.
Tekmira received the clinical hold letter from the FDA in July concerning the TKM-Ebola Phase I trial. For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page