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Enrolment stops for Phase II TKM-Ebola-Guinea trial
23 June 2015 • Author: Victoria White
Tekmira has announced that the Phase II clinical trial of TKM-Ebola-Guinea has reached a predefined statistical endpoint and enrolment has been closed.
The endpoint indicated that continuing enrollment was not likely to demonstrate an overall therapeutic benefit.
“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.
Full results from the Phase II trial of TKM-Ebola-Guinea will be made available
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.
Data analysis is ongoing and the full results will be made available as soon as possible.
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