10.04.2015 17:08:19
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FDA Allows Tekmira To Contnue Clinical Study Of Ebola Treatment
(RTTNews) - Tekmira Pharmaceuticals Corp. (TKMR, TKM.TO) Friday said the U.S. Food & Drug Administration has allowed the company to continue the clinical test of its drug for Ebola.
Tekmira said FDA notified it that the partial clinical hold on for TKM-Ebola has been modified 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.
Last July, FDA had placed a clinical hold on TKM-Ebola Phase I healthy volunteer study due to safety concerns.
TKM-Ebola is an anti-Ebola virus RNAi therapeutic. It is being developed by Tekmira along with the U.S. Department of Defense.
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