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