WASHINGTON - US regulators loosened restrictions on a new experimental drug for treating Ebola, which may allow it to be tried on infected patients in West Africa, the company said yesterday.
The Canada-based company, Tekmira, said the US Food and Drug Administration changed the classification of its drug TKM-Ebola from full clinical hold to partial hold.
"This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus," said a company statement.
Tests on monkeys have shown the drug provided 100 percent protection from an otherwise lethal dose of Ebola, the company said.
West Africa is experiencing the largest outbreak of Ebola in history. The virus has killed 932 people of more than 1,700 infected, and the disease continues to spread.
"This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus," said Mark Murray, CEO and president of Tekmira Pharmaceuticals.
"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."
TKM-Ebola is being developed under a $140 million contract with the US Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office.
The drug, described as an anti-Ebola virus RNAi therapeutic, is designed to be given in multiple doses, which is not always practical in a mass outbreak.
However, there are no drugs on the market to treat Ebola and no vaccines against it.
The rapidly growing outbreak in West Africa has sped up the process of getting experimental therapies to market, though experts say it may be months before production can be scaled up and the drugs delivered to those in need.
The two American missionaries who were evacuated from Liberia in recent days were given a different experimental serum known as ZMapp.
Both Kent Brantly and Nancy Writebol are improving, but health authorities say it is too early to tell if the drug had anything to do with that.
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