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Local company halts trials on Ebola vaccine
As fears grow about the Ebola virus spreading beyond Africa, a Burnaby company has had its clinical trial for a new vaccine to treat the disease put on hold by the U.S. Food and Drug Administration.
Tekmira Pharmaceuticals, located in the Glenlyon business park, had been in the first phase of trials on healthy human volunteers of its TKM-Ebola vaccine.
But the FDA said it needs more information to ensure the safety of healthy volunteers before it can allow the trial to resume.
Prior to the hold on its testing, Dr. Mark Murray, the president and CEO of Tekmira, said the results for its Ebola medication were promising as the volunteers were able to tolerate heavy doses of the vaccine without any sort of pre-medication like steroids.
“The multiple ascending dose portion of the study, as originally proposed, reflects the intense dosing regimen that would be used in patients lethally infected with Ebola virus,” said Murray.
He said the company is assembling the data requested by the FDA and will modify its protocol to ensure the safety of the volunteers.
“Our team is working expediently to respond to the FDA,” said Murray. “We are mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa.”
That outbreak has already killed more than 900 people over the past six months. Last week two American health care workers who had been volunteering in Africa were flown back to Atlanta for specialized treatment in a hospital isolation ward after they contracted the highly infectious disease.
Ebola is a hemorrhagic fever that is spread by contact with bodily fluids. It is almost always fatal.
Tekmira’s vaccine project is one of several in various stages of testing, but none are yet available for treatment. The company is developing its vaccine under a $140 million contract with the U.S. Department of Defense and in March it was granted a fast track designation by the FDA.