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Benitec delays IND filing for HIV/AIDS therapeutic pending resolution of manufacturing result

09 Feb 2006 - Benitec Ltd. announced 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."