Canadian bio-pharmaceuticals company Tekmira said Friday that the U.S. FDA has allowed it to resume the Phase-I clinical trials of its experimental Ebola treatment TKM-Ebola. Tekmira can test its experimental treatment on a small number of healthy people at a lower dose. The Burnaby-based company said it would start clinical studies in the next few weeks.
TKM-Ebola to remain on partial hold above 0.24mg/kg
With this, the FDA has altered the terms of a partial clinical hold on TKM-Ebola. The treatment works by blocking genes that help Ebola virus reproduce and spread. Tekmira started clinical studies by giving single doses to healthy volunteers in 2014. But the FDA stopped the clinical study in July 2014 as it sought more information about the safety of higher doses.
In May 2014, Tekmira had reported that a dose of 0.30mg/kg per day was well tolerated in patients suffering from Ebola. But FDA’s modified terms allow it to use doses below 0.24mg/kg per day. The drug remains on partial clinical hold above 0.24mg/kg per day. Some subjects in the study will receive TKM-Ebola while others will get a placebo injection for up to seven days.
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Tekmira expects results in 2H, 2015
The company expects to provide results of the study in the second half of this year. Tekmira is developing the drug under a $140 million contract with the U.S. Department of Defense. The Canadian company does not have any approved drug in the market. It is also conducting clinical trials for TKM-HBV, its experimental drug for Hepatitis B virus.
Meanwhile, Tekmira started phase II clinical trials of a special variant of TKM-Ebola in Sierra Leone, West Africa last month. This variant, called TKM-Ebola-Guinea, specifically targets the Guinea strain of Ebola virus that is responsible for the epidemic in African countries. Tekmira is expecting results in the second half of 2015.
Tekmira shares rallied 3.13% to $18.74 at 10:04 AM EDT on Monday.