Tekmira Pharmaceuticals announced Monday that the FDA and Health Canada will permit the company to provide the experimental therapy TKM-Ebola for treatment under expanded access protocols to individuals with confirmed or suspected Ebola virus infections. Tekmira CEO Mark J. Murray commented "an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients." Shares in the drugmaker rose more than 14 percent on the news.
A World Health Organization panel concluded last month that it would be ethical to use experimental Ebola therapies and vaccines to fight the ongoing Ebola outbreak under certain conditions. "We have already responded to requests for the use of our investigational agent in several patients under emergency protocols, in an effort to help these patients, a goal we share with the FDA and Health Canada," added Murray.
Tekmira stated that TKM-Ebola has been administered to a number of patients, with repeat infusions being well-tolerated. The drugmaker however noted that the use of the therapy under controlled access programmes does not constitute a clinical trial and that some 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," Murray said. The company further cautioned that its supply of TKM-Ebola is "limited."
Last month, Tekmira reported that the FDA partially lifted a clinical hold on an early-stage study of TKM-Ebola, permitting a part of the trial to proceed. The FDA granted fast-track designation to the therapy, which is being developed under a $140-million contract with the US Department of Defense, in March.
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