Tekmira Pharmaceuticals Corp (NASDAQ:TKMR) got the nod for testing of its Ebola treatment on healthy volunteers. The partial clinical hold on the company was modified to allow the testing. Tekmira is developing the drug jointly under a $140 million contract with a bio defence arm of Defence forces. Tekmira’s shares rose 2% after the news was announced.
USFDA had put the drug, known as TKM-Ebola on clinical hold until more data could be provided on safety and effectiveness. In August, the company was allowed to use its drug on suspected Ebola patients. The drug was given fast-track testing status in March 2014 however increased doses during trial caused concerns.
The company will now resume its Phase I clinical trial in the next few weeks. The trial is a randomized, single-blind study in which the subject receives daily doses of drugs or placebo. The USFDA has set a limit of 0.24 mg/kg per day of the treatment.
TKM-Ebola is on partial clinical hold for doses above 0.24 mg/kg per day according to Tekmira. The company reported in interim results that a dosage of 0.30 mg/kg per day was well tolerated.
Healthy volunteers will be given a set amount of dosing for a week; Tekmira Pharmaceuticals Corp (NASDAQ:TKMR) expects to get the results from the testing by the latter half of the year. The drug has been tested on primates and gives 100% protection from Ebola even with lethal doses of Ebola.
Other development on Ebola treatment came from an on-going testing at the University of Texas’s medical branch. The vaccine developed there protected rhesus macaques from Ebola. In the research, eight macaques were injected with Ebola, none of the vaccinated macaques showed any signs of Ebola.
Ebola hit the West African nations hard last year. The disease has infected more than 25,000 people in many companies. In America, four cases have been reported.