Friday, June 19, 2015

Clinical Trial Of Ebola Drug TKM-Ebola Halted, No Therapeutic Benefit

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Sometimes drugs that looked promising in animal trials turn out to be less than stellar performers once they move into human testing.  Apparently, such is the case with Tekmira’s TKM-Ebola drug which began phase II clinical trials last March in Sierra Leone.


The drug – a reworking of an earlier Experimental Ebola drug designed to combat the Kitwit version of Ebola – was reformulated to inhibit the replication of the Guinea strain (aka “Ebola virus Makona")  in West Africa. 

 

The drug, which must be infused over a 2-hour period via IV, appeared to work well on monkeys, but was unable to deliver `an overall therapeutic benefit’ to patients in the the phase II trial.


Two statements: First one from Welcome Trust, who provided funding for this phase II clinical trial, followed by one from the manufacturer; Tekmira.

 

Update on Ebola treatment trial in Sierra Leone

19th June 2015

A clinical trial of a potential treatment for Ebola, called TKM-Ebola-Guinea, is no longer recruiting patients after reaching a pre-defined endpoint. Early results indicated that continued enrolment to the study, which has been running since March 2015 in Sierra Leone, was unlikely to demonstrate an overall therapeutic benefit to patients.

The research team is currently analysing the data collected during the trial and will make the results available as soon as possible. The single-arm phase II study (RAPIDE-TKM), is led by Professor Peter Horby of the University of Oxford on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) in collaboration with the College of Medicine and Allied Health Sciences in Sierra Leone. The study is funded by the Wellcome Trust.

Professor Horby, Associate Professor of Infectious Diseases and Global Health at the University of Oxford and Chief Investigator of the study, said: "It is a great tribute to our colleagues in Sierra Leone that the trial has been run so efficiently and that we now have substantial experience on the use of TKM-Ebola-Guinea in patients with Ebola.

“While the trial has reached a statistical endpoint, and has therefore completed, final conclusions on the efficacy and tolerability of the drug must await full analysis of the data."

TKM-Ebola-Guinea, is a synthetic small interfering RNA (siRNA) therapeutic developed and manufactured by Tekmira Pharmaceuticals. It is one of a number of candidate Ebola treatments to be evaluated through the Wellcome Trust Ebola therapeutics platform, which was set up in September 2014 to enable multiple partners to quickly establish clinical trials at existing Ebola treatment centres.

 

          June 19, 2015

Tekmira Provides Update on TKM-Ebola-Guinea

Phase 2 clinical trial enrollment closed
Data analysis ongoing, full results pending

VANCOUVER, British Columbia and DOYLESTOWN, Pa., June 19, 2015 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), today announced that the Phase II clinical trial of TKM-Ebola-Guinea has reached a predefined statistical endpoint and enrollment has been closed. The endpoint indicated that continuing enrollment was not likely to demonstrate an overall therapeutic benefit. Data analysis is ongoing and the full results will be made available as soon as possible.

"It is a great tribute to the team in Sierra Leone that the trial has been run so efficiently and that we now have substantial experience on the use of TKM-Ebola-Guinea in patients with Ebola. While the trial has reached a statistical endpoint, final conclusions on the efficacy and tolerability of the drug must await full analysis of the data," said Dr. Peter Horby, Associate Professor of Infectious Diseases and Global Health, University of Oxford, Chief Investigator on the study.

In this trial, TKM-Ebola-Guinea is being evaluated for efficacy in Ebola virus infected patients in Sierra Leone, West Africa. The Phase II single arm trial called RAPIDE (Rapid Assessment of Potential Interventions & Drugs for Ebola) is open-label with a concurrent observational study of Ebola virus disease in Sierra Leone.

The University of Oxford, which is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) is responsible for conducting the Phase II study, with funding provided by the Wellcome Trust.

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