RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals (TKM) and the University of Oxford have reached a manufacturing and clinical trial agreement to test the new TKM-Ebola-Guinea drug in humans.
As part of the agreement, Tekmira’s Ebola drug will be made available in West Africa for clinical studies that are likely to start in early 2015.
Tekmira president and CEO Dr Mark Murray said: "We are very pleased that TKM-Ebola-Guinea will be studied in patients and result in benefit to them.
"While the clinical protocol is still being finalised, the studies are designed to establish efficacy, so that an effective therapeutic can be available to patients."
The clinical studies will be funded by the Wellcome Trust and is scheduled to be carried out by the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC).
Developed as anti-Ebola RNAi therapeutic targeting Ebola-Guinea, Tekmira’s new TKM-Ebola-Guinea is designed to match the genomic sequence exactly, with two RNAi triggers.
Dr Murray added: "TKM-Ebola-Guinea underscores how RNAi-based technology allows for rapid response to emerging viral variants."
During the preclinical studies, TKM-Ebola-Guinea showed efficacy results that were comparable to those obtained with TKM-Ebola, which has demonstrated up to 100% protection from an otherwise lethal dose of the virus.
Under a $140m contract, TKM-Ebola is being developed along with the US Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (JPM-MCS-BDTX) Joint Product Management Office.
The US Food and Drug Administration granted a fast-track designation for the development of Tekmira TKM-Ebola in March this year.
Image: Colourised transmission electron micrograph (TEM) revealed some of the ultrastructural morphology displayed by an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.