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Benitec Submits HCV Drug Trial Protocol to NIH’s RAC

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Benitec Biopharma said this week that it has submitted an application to the National Institutes of Health’s Recombinant DNA Advisory Committee, or RAC, detailing the protocol for its proposed phase I trial of the expressed RNAi hepatitis C treatment TT-034.

The RAC was established in 1974 to address concerns over the safety of using recombinant DNA techniques to manipulate genetic material. Since TT-034 comprises a multi-cassette vector designed to express shRNAs targeting three areas of the HCV genome, Benitec is required to submit it to the RAC for review prior to beginning human trials.

Benitec said that the review could be administrative or require a public hearing, which would likely be held at the next RAC meeting in June.

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