Benitec delays filing IND for HIV/AIDS drug due to manufacturing issue

By E. Janene Geiss

Philadelphia, Jan. 31 - Benitec Ltd. announced Tuesday that it would delay the Investigational New Drug Application filing for its HIV/AIDS therapeutic due to one aberrant result in the release of tests of the clinical materials, not the drug itself.

"We are working closely with the manufacturing team to resolve this unanticipated result and will move forward as quickly as possible with the IND filing," said Sara M. Cunningham, chief executive officer, in a company news release.

"Although the result is unrelated to the safety or efficacy of the drug, we will not file the IND until we are certain that all components of the clinical materials are fully and properly characterized and pass our stringent manufacturing criteria," Cunningham added.

Benitec is a Mountain View, Calif., biotechnology company focused on developing therapeutics to treat serious diseases using proprietary RNAi technology.

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