A hold on clinical trials for a drug developed by Vancouver’s Tekmira Pharmaceuticals Corp. (TSXTKM) for treating the Ebola virus has been partially lifted, the company reports.
One of the drugs Tekmnira has been developing is TKM-Ebola. The company had been conducting phase one trials, but the American Food and Drug Administration placed a hold on it. A clinical hold means an investigational drug cannot be used on humans.
But on Thursday (August 7), Tekmira announced that the FDA has verbally confirmed that hold has been changed to a partial clinical hold, which means the drug can now be tested on humans infected with the virus.
“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients,” said Tekmira CEO Mark Murray.
“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.”
To date, an Ebola outbreak in Africa has killed more than 900 people, and regulators are under pressure to fast-track any drug that might be used against the virus, which has a 90% fatality rate.
“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.”
