MOUNTAIN VIEW, Calif., Jan. 31 /PRNewswire-AsiaNet/ –
Benitec Ltd. (ASX: BLT), 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
SOURCE Benitec Ltd.
CONTACT:
Laurie Reisinger of Benitec Ltd.,
+1-650-564-9850 ext.1101,
lreisinger@benitec.com
Web site: http://www.benitec.com
January 31, 2006
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