B.C.'s Tekmira gets FDA approval to fast track Ebola drug
Stock up 22% as doors opened for human trials on infected patients
Tekmira Pharmaceuticals Corp. saw its stock jump more than 22 per cent Friday morning after announcing it has verbal approval from the U.S. Food and Drug Administration that would fast track its new drug to treat the Ebola virus.
Today the World Health Organization declared the Ebola outbreak in West Africa to be an international public health emergency and called for extraordinary measures to combat it.
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News that the FDA has applied a “partial clinical hold” on Tekmira’s treatment could clear the way for use of the drugs on infected individuals, the company said in a statement.
The company started an early stage human clinical trial for the treatment in January and was granted fast-track status from the U.S. FDA on March 5, pushing shares to their highest level, above $33.
The trial was put on hold July 3, when some of the patients in the trial experienced problematic immune responses.
The company still is on clinical hold for the multi-ascending dose portion of the study on healthy patients.
But the FDA approval will make it possible for single ascending doses to be given to infected patients.
“We are pleased that the FDA has considered the risk reward of TKM-Ebola for infected patients,” Dr. Mark Murray, CEO of the B.C.-based company said in a statement Friday.
“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.”
TKM-Ebola is being developed by Tekmira and the U.S. Department of Defence medical team.
Another Ebola treatment, Z-Mapp was used to treat two American aid workers affected with the virus. It was developed by Mapp Biopharmaceutical, Inc. and LeafBio of San Diego, Calif, and Defyrus Inc. of Toronto.
Ebola belongs to a family of viruses that can cause serious hemorrhagic fevers. The recent outbreak, which has killed more than 1,000 people since February, is the worst since the disease was discovered in the mid-1970s.