AVI BioPharma, Inc. (AVII: Quote) Tuesday announced that the U.S Food and Drug Administration, or the FDA, has granted approval to the company to proceed with a single oligomer, AVI-7288, in studies in both humans and non-human primates to support the safety and efficacy of post-exposure prophylaxis against Marburg virus infection.
The company stated that AVI-7288 is one of two components that make up AVI-6003.
The company further added that it will proceed with dosing AVI-7288 in the Phase I multiple ascending dose studies planned to characterize the safety, tolerability and pharmacokinetics of multiple doses of the drug in healthy adult volunteers.
"While we have not seen any toxicity in humans to date with AVI-6003, by removing AVI-7287 we have a simpler development path and may improve the therapeutic window by evaluating a single action agent," said Chris Garabedian, president and CEO of AVI BioPharma. "We are pleased to be able to explore this single oligomer as a potentially safe and effective treatment against this lethal hemorrhagic fever virus."
by RTT Staff Writer
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