08.08.2014 00:23:26
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FDA Enables Potential Human Use Of Tekmira's Ebola Drug
(RTTNews) - Tekmira Pharmaceuticals Corp. (TKMR, TKM.TO) said THursday that the U.S. Food & Drug Administration has verbally confirmed it has modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application to a partial clinical hold.
The FDA action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.
TKM-Ebola is being developed by Tekmira and the U.S. Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office.
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.
In March 2014, Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola.
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