Benitec Limited Delays IND Filing For HIV/AIDS Therapeutic Pending Resolution Of Manufacturing Result

MOUNTAIN VIEW, Calif., Jan. 31 /PRNewswire-FirstCall/ -- Benitec Ltd. , a leading developer of RNA interference (RNAi)-based therapeutics, announced today that the Investigational New Drug (IND) filing with the US Food & Drug Administration (FDA) for its HIV/AIDS therapeutic will be delayed. The delay is due to one aberrant result in the release tests of the clinical materials, not the drug itself.

Sara M. Cunningham, Chief Executive Officer of Benitec, stated, “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. 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.

“We know that the manufacturing process for any new biological formulation is rarely smooth. We remain deeply committed to this product, as preclinical studies show that it presents an entirely new therapeutic avenue and offers a last line of defense for AIDS/Lymphoma patients who have relapsed from conventional treatments.”

About Benitec

Benitec is an international biotechnology company focused on developing therapeutics to treat serious diseases using its proprietary RNAi technology. Benitec is listed on the Australian Stock Exchange and has its operations centered in Mountain View, California, USA. Its lead therapeutic programs are for Hepatitis C Virus (HCV) and the Human Immunodeficiency Virus (HIV). Benitec’s RNA-based HIV/AIDS therapeutic, co-developed with the Center for Biomedicine & Genetics at the City of Hope in Los Angeles, California, will enter Phase I clinical trials in 2006. Benitec’s RNAi therapeutic for HCV will enter clinical trials in 2007. For additional information, please visit http://www.benitec.com.

Forward-looking Statements

This press release contains forward-looking statements that reflect the Companies’ current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Companies’ research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.

CONTACTS: BENITEC LTD. Laurie Reisinger +1 650 564 9850 ext.1101 lreisinger@benitec.com

Benitec Ltd.

CONTACT: Laurie Reisinger of Benitec Ltd., +1-650-564-9850 ext.1101,lreisinger@benitec.com

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