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Re: BLT - Benitec Limited
Benitec Phase I Study Update
2 April 2007, Melbourne, Australia: The Directors of Benitec Limited (ASX: BLT) are delighted to announce that the Phase I study in HIV in collaboration with City of Hope should commence shortly.
The Investigational New Drug (IND) application was submitted in late January to the U.S. Food and Drug Administration (FDA), which has requested one additional safety test for the virus lot and additional information regarding several reagents used in the virus manufacture. The additional virus safety study is underway and will take approximately 4 weeks to complete. Pending final submission of these results to FDA and approval to proceed, we expect recruitment to commence soon.
This IND study being undertaken in collaboration with City of Hope is entitled “A pilot study of safety and feasibility of stem cell therapy for AIDS lymphoma using stem cells treated with lentivirus vector-encoding multiple Anti-HIV RNA’s”. The vector rHIV7-shI-TAR-CCR5RZ was manufactured by City of Hope’s Center for Biomedicine and Genetics. More details on the study will be provided when the trial commences.
“We are pleased that we are close to being ready to commence the Phase I study in this group of patients. This is the first human trial using Benitec technology and we are very fortunate to be working with such world class investigators and the team at the City of Hope” said Sue MacLeman, CEO, Benitec Limited.
Benitec Phase I Study Update
2 April 2007, Melbourne, Australia: The Directors of Benitec Limited (ASX: BLT) are delighted to announce that the Phase I study in HIV in collaboration with City of Hope should commence shortly.
The Investigational New Drug (IND) application was submitted in late January to the U.S. Food and Drug Administration (FDA), which has requested one additional safety test for the virus lot and additional information regarding several reagents used in the virus manufacture. The additional virus safety study is underway and will take approximately 4 weeks to complete. Pending final submission of these results to FDA and approval to proceed, we expect recruitment to commence soon.
This IND study being undertaken in collaboration with City of Hope is entitled “A pilot study of safety and feasibility of stem cell therapy for AIDS lymphoma using stem cells treated with lentivirus vector-encoding multiple Anti-HIV RNA’s”. The vector rHIV7-shI-TAR-CCR5RZ was manufactured by City of Hope’s Center for Biomedicine and Genetics. More details on the study will be provided when the trial commences.
“We are pleased that we are close to being ready to commence the Phase I study in this group of patients. This is the first human trial using Benitec technology and we are very fortunate to be working with such world class investigators and the team at the City of Hope” said Sue MacLeman, CEO, Benitec Limited.