NEW YORK (GenomeWeb) – Tekmira Pharmaceuticals this week announced that it has received clearance from the US Food and Drug Administration to provide its experimental Ebola drug, called TKM-Ebola, to individuals with confirmed or suspected infections under expanded access protocols.
On the news, Tekmira shares rose more than 5 percent to $21.38 in Monday morning trading.
"We have already responded to requests for the use of our investigational agent in several patients under emergency protocols," Tekmira President and CEO Mark Murray said in a statement. "TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated.
Murray added, however, that "any uses of the product under expanded access does not constitute controlled clinical trials. These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome."
TKM-Ebola has already advanced into Phase I testing, but in July the FDA ordered Tekmira to halt the multi-dose portion of that trial until it received additional information about cytokine induction observed in those who had received the highest dose of the drug in the study's single-dose arm.
In August, Tekmira said it expects to address the FDA's concerns and restart the study by the end of the year.
The company also announced that it has joined an international consortium working to run clinical trials of Ebola therapies in West Africa.
The consortium also includes representatives from the World Health Organization, the US Centers for Disease Control, and Doctors without Borders, among others. It is being funded by a £3.2 million ($5.3 million) grant from the Wellcome Trust.
According to Tekmira, it will produce an RNAi-based therapeutic specifically designed to target the viral variant responsible for the current outbreak, which may be selected for testing at the clinical centers established by the consortium.