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Tekmira signs TKM-Ebola-Guinea clinical trial agreement with Oxford University

Canadian RNAi therapeutics developer Tekmira Pharmaceuticals (TKM) has entered into a manufacturing and clinical trial agreement with the University of Oxford to test the new TKM-Ebola-Guinea drug in humans.

Under the deal, Tekmira’s Ebola drug will be made available in West Africa for clinical trials which are expected to start in early 2015.

Funded by the Wellcome Trust, the new trials will be carried out by the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC).

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."

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.

In 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.

As part of the $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.

In March 2014, the US Food and Drug Administration (FDA) granted a Fast Track status for the development of Tekmira TKM-Ebola.