FDA modifies partial clinical hold on TKM-Ebola Investigational New Drug application
Posted: 13 April 2015 |
The FDA has modified the partial clinical hold on the IND for TKM-Ebola to permit repeat dosing of healthy volunteers at a dose of 0.24 mg/kg/day…
Tekmira has announced that the U.S. Food and Drug Administration (FDA) has modified the partial clinical hold on the company’s Investigational New Drug application (IND) for TKM-Ebola to permit repeat dosing of healthy volunteers at a dose of 0.24 mg/kg/day.
The IND remains on partial clinical hold with regard to doses above 0.24 mg/kg/day in healthy volunteers.
TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. Earlier preclinical studies demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus. In March 2014, Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola.
Results from the TKM-Ebola Phase I trial are expected later in 2015
Tekmira plans to resume the TKM-Ebola Phase I clinical trial in the coming weeks. The study is a randomised, single-blind, placebo-controlled study involving repeat dosing of a single cohort of healthy volunteers. Each subject will receive daily doses of 0.24mg/kg of TKM-Ebola or placebo for up to seven days. TKM-Ebola will be administered without steroid pre-medication. Results from the study are expected in the second half of 2015.
In July 2014, the Company received notice from the FDA placing the TKM-Ebola IND on clinical hold until additional information was provided and the multiple ascending dose portion of the trial protocol was modified to ensure the safety of healthy volunteers. The clinical hold was subsequently modified in August to a partial clinical hold to permit the administration of TKM-Ebola to patients with a suspected or confirmed Ebola virus infection.
For more information about Tekmira Pharmaceuticals Corporation, please visit www.tekmira.com.
