Sarepta Therapeutics,
Inc. SRPT, a developer of innovative RNA-based
therapeutics, today announced that the Company has 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 (ClinicalTrials.gov
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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