September 23, 2014
By Krystle Vermes, BioSpace.com Breaking News Sr. Editor
Tekmira Pharmaceuticals has received authorization from the U.S. Food and Drug Administration to provide TKM-Ebola for treatment under expanded access protocols, the company said late Monday.
It will be administered to people with confirmed or suspected Ebola virus infections. This news comes following the continuation of the largest Ebola outbreak in history, situated in West Africa, according to the Centers for Disease Control and Prevention. Canadian regulators had already cleared the drug for use.
“Tekmira is reporting that an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients,” said Mark Murray, Tekmira’s president and chief executive officer. “We have worked with the FDA and Health Canada to establish this framework and a treatment protocol allowing us to do what we can to help these patients.”
TKM-Ebola is an investigational therapeutic, which is being developed under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. Preclinical studies that have been published in The Lancet show that when non-human, infected primates were given the drug, the result was 100 percent protection from an otherwise lethal dose of Zaire ebola virus. The FDA gave Tekmira a fast track designation in March for the development of TKM-Ebola.
“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,” Murray said. “TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated.”
Tekmira stressed that it must be kept in mind that any uses of the product under expanded access does not constitute controlled clinical trials. “These patients may be infected with a strain of bola 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,” said Murray.
Murray went onto say that Tekmira has a limited supply of TKM-Ebola, but the company will continue to help where it can.
A report today from the Centers for Disease Control and Prevention estimated that Liberia and Sierra Leone could have 21,000 cases of ebola by Sept. 30, and 1.4 million cases by Jan. 20, if the disease keeps following its current trajectory.
Tekmira Pharmaceuticals is a biopharmaceutical company that focuses on advancing RNAi therapeutics and providing its lipid nanoparticle delivery technology to its partners. Tekmira has been working in the field of nucleic acid delivery for more than a decade.
