08.08.2014 06:03:14
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Tekmira: FDA Enables Potential Use Of TKM-Ebola In Ebola-infected, Stock Surges
(RTTNews) - Tekmira Pharmaceuticals Corp. (TKMR, TKM.TO) Thursday said the U.S. Food & Drug Administration has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application or IND to a partial clinical hold. The stock added over 8 percent in the extended trade.
This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.
TKM-Ebola is an anti-Ebola virus RNAi therapeutic. It is being developed by Tekmira Pharmaceuticals and the U.S. Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office.
The TKM-Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study and involves single ascending doses and multiple ascending doses of TKM-Ebola.
The study assesses the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy adult volunteers without administering any steroid pre-medications.
The company remains on clinical hold as it relates to the multi-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola.
TKMR closed up 6.7 percent at $14.27 on Thursday and added 8.1 percent in the extended trade.
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