Benitec Limited (ASX:BLT) T Cell HIV Trial Open For Recruitment

Melbourne, April 12, 2010 AEST (ABN Newswire) - The Directors of Benitec Limited (ASX:BLT) (PINK:BNIKF) announced today that its second HIV-targeted clinical trial is open for recruitment following favourable review and approval of the protocol and associated documents by the Institutional Review Board of City of Hope, California, and the US Food and Drug Administration (FDA).

The study's title is "A pilot study of the safety and feasibility of a therapy for AIDS lymphoma using T-cells treated with a lentiviral vector encoding multiple anti-HIV RNAs".

The Phase I study utilises a triple vector which includes one component utilising Benitec's DNA-directed RNA interference technology, along with two other proprietary RNA technologies which the Company has an option to license. The rationale of the study is the HIV will be unable to replicate in T cells as the triple vector targets three separate stages in the HIV replication cycle. The reason for using a triple vector is to reduce the chance that HIV can develop resistance to the therapy.

The study aims to enrol five HIV positive patients aged between 18 and 60 years of age who have been on Highly Active AntiRetroviral (anti-HIV) Therapy (HAART) therapy for at least one year and have evidence of treatment failure.

In the study, which will be conducted at City of Hope, Duarte, California, with Dr John Zaia from City of Hope's Beckman Research Institute as the Principal Investigator, patients' own T cells will be transfected with the triple vector and then re-infused into their bloodstream. This will be done three times per patient.

The primary endpoints of this pilot study are patient safety and study feasibility. Safety will be determined by clinical and laboratory observation and grading of adverse events, analysis of T cell repertoire clonality, and evaluation of HIV isolates for evidence of vector recombination. Feasibility will be determined by the ability to obtain suitable numbers of expanded T cells and expression of the RNA transgenes in these cells. The secondary endpoints are the duration of T cell circulation in blood post-infusion and the effect of the T cell infusion on CD4 count and on HIV load. It is estimated that the recruitment of all patients will take up to 18 months to complete.

"The commencement of patient recruitment in our HIV T cell study is a significant milestone delivered by Benitec, and we look forward to its successful progress under the guidance of Dr John Zaia and his team," said Mr Mel Bridges, Executive Director, Benitec Ltd.

Dr John Zaia said, "Benitec's technology, coupled with two other proprietary anti-HIV RNA constructs, has the potential to provide a novel therapy for HIV. This trial will ensure that the use of the therapy is safe and feasible for this purpose, and we are excited to be able to deliver it to the clinic."

Contact

Mr Mel Bridges Benitec Limited Mob: +61-413-051-600 Email: melbridges@parmacorp.com