Sarepta (SRPT) Enters CTA with NIAID for AVI-7100 Phase I

December 21, 2012 8:31 AM EST
Sarepta Therapeutics, Inc. (Nasdaq: SRPT) entered into a Clinical Trial Agreement (CTA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to conduct a Phase I study with AVI-7100, the Company's lead drug candidate with a novel mechanism of action and potentially broad-spectrum activity against influenza viruses, including Tamiflu-resistant virus strains.

The agreement establishes a formal collaboration between NIAID and Sarepta to allow NIAID researchers to proceed with a Phase I, double-blind, placebo-controlled, dose-escalating study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of an intravenous formulation of AVI-7100 in healthy volunteers. The trial is being conducted at the NIH Clinical Center in Bethesda, MD, under the direction of Richard Davey, M.D., of NIAID's Division of Intramural Research ( Identifier: NCT01747148). Per the terms of the agreement, Sarepta will provide AVI-7100 to NIAID. In return, Sarepta will have the right to use the data from this clinical study to support future development of AVI-7100.

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