Tekmira Pharmaceuticals announced this week that the they have entered into a Manufacturing and Clinical Trial Agreement with the University of Oxford to provide the new TKM-Ebola-Guinea therapeutic product for clinical studies in West Africa.
The studies are expected to commence early next year, subject to finalization of a suitable clinical protocol.
The University of Oxford is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). ISARIC will conduct clinical studies of TKM-Ebola-Guinea in Ebola virus infected patients, with funding provided by the Wellcome Trust. GMP manufacture of TKM-Ebola-Guinea is now complete and 100 treatment courses are available for the study.
“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 finalized, the studies are designed to establish efficacy, so that an effective therapeutic can be available to patients,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
In early October, the genomic sequence of the Ebola-Guinea variant, which is responsible for the current outbreak in West Africa, was determined from several viral isolates and was published in the New England Journal of Medicine. Tekmira developed a modified RNAi therapeutic to specifically target the Ebola-Guinea variant. The new product, TKM-Ebola-Guinea, is designed to match the genomic sequence exactly, with two RNAi triggers.
Results of preclinical studies with TKM-Ebola-Guinea demonstrated efficacy results comparable to those obtained with TKM-Ebola, which has demonstrated up to 100% protection from an otherwise lethal dose of the virus.
“TKM-Ebola-Guinea underscores how RNAi-based technology allows for rapid response to emerging viral variants,” said Dr. Murray.
The Ebola-Guinea strain is the virus responsible for the current outbreak in West Africa. This strain diverges slightly from the Kikwit strain, which was the original target of TKM-Ebola.