Breaking News, Trials & Filings

Tekmira Ebola Formulation Approved for Trials

FDA clears new formulation utilizing LNP improvements, lyophilization

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Tekmira has received clearance to proceed with the use of a more potent formulation in its TKM-Ebola Phase I clinical trial, which is expected to begin enrolling patients early next year. The company must get IRB approval of its FDA-approved clinical protocol before enrolling healthy volunteer subjects in a Phase I trial. The company plans to dose its first patient in 1Q14. TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a contract with the U.S. Department of Defense’s...

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