Back in May as the Ebola epidemic began exploding through west Africa, an RNA interference therapy from Tekmira Pharmaceuticals was the only drug for the deadly virus that had reached clinical trials.
In extensive earlier tests of non-human primates, the Tekmira-Ebola drug “is essentially 100% efficacious,” president Mark Murray told me then.
When I asked Murray if his company’s drug could be used in Africa, he patiently explained how the process works: If the safety trial among healthy human volunteers continued to go well, the drug would be tested again for efficacy in non-human primates next year and finally for safety once more in a larger group of healthy people, before being stockpiled.
So prospects for delivering the Tekmira-Ebola drug for the current outbreak seemed unlikely. They seemed unlikelier still in July when the FDA put a clinical hold on the trials after a flu-like inflammatory response cropped up among some of the volunteers.
As the Ebola epidemic grew ever more horrific and heartbreaking, though, and two U.S. health workers were treated back in this country with another experimental drug, the FDA gave a thumbs-up for giving Tekmira’s drug to patients in the U.S.
Last week the company acknowledged it was considering appropriate delivery in Africa as well. “Given the severity of the situation, we are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols,” it stated. “This includes discussions with government agencies and NGOs, including the WHO.”
The current Ebola epidemic eventually will be controlled by standard public health measures, in countries that are desperately ill equipped to provide them. Experimental medicines like Tekmira-Ebola will only be given on request from medical authorities in Africa, will offer significant risks to patients and won’t be ready in volume for months at best. But I hope that they do save some lives now, and many more lives in years to come.