November 7, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Canada-based Tekmira Pharmaceuticals has received approval from the U.S. Department of Defense to make 500 courses of its experimental Ebola drug, according to Reuters. The news came on Nov. 6 as West Africa continues to battle an Ebola outbreak that has claimed more than 5,000 lives.
The Tekmira treatment is designed to target the Ebola-Guinea virus variant, which is responsible for the outbreak. The treatment works by preventing the virus from replicating within the body. It will be available as soon as early December, and it will be used in clinical studies across West Africa, according to Tekmira.
Tekmira conducts its program under a $140 million contract with the U.S. Department of Defense. The value of an option to produce the drug is $7 million.
“In September, we announced our active engagement with an International Consortium led by the International Severe Acute Respiratory and Emerging Infections Consortium, the University of Oxford, with representatives from the WHO, the U.S. Centers for Disease Control, Médecins Sans Frontières, Institut Pasteur and others, on plans for potential expedited clinical trials in West Africa,” Tekmira said in a statement. “The Wellcome Trust has awarded £3.2 million to the International Consortium to fund this initiative.”
In the past, the U.S. Food and Drug Administration authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to patients with Ebola infections. However, supplies of the drug quickly diminished. Now, Tekmira has confirmed its dedication to providing TKM-Ebola to patients under existing regulatory framework, despite the challenges.
Tekmira announced that it would be joining the International Consortium back in September to create an RNAi based investigational therapeutic for clinical studies out in West Africa.
“We are an active collaborator in this consortium and through our ongoing dialogue with the WHO, NGOs and governments in various countries; we have been discussing the creation of appropriate clinical and regulatory frameworks for the potential use of investigational therapeutics in Africa,” Mark Murray, Tekmira president and CEO, stated at the time of the initial collaboration. “This initiative goes a long way towards achieving this aim. Many complex decisions remain to fully implement this unique clinical trial platform.”
Tekmira specializes in RNAi therapeutics, which have the potential to “silence” disease causing genes. The company is known for its lipid nanoparticle delivery technology that is currently being used by many of its pharmaceutical partners.
