Benitec appoints Clinical Research Organisation for Hepatitis C...

Benitec appoints Clinical Research Organisation for Hepatitis C clinical trial

Key Points:

• Benitec Biopharma appoints Synteract Inc, a US-based Clinical Research Organisation,
with extensive Hepatitis C clinical trial experience
• Synteract Inc will assist in the preparation of regulatory submissions and manage the Phase I/IIa clinical trial for TT-034, a gene silencing therapeutic for treatment of patients infected with the Hepatitis C virus (HCV)
• The appointment is a key milestone in advancing the program into the clinic.

Sydney, Australia December 18, 2012: Benitec Biopharma Ltd (ASX: BLT) today announced the appointment of Synteract Inc, a US-based clinical research organisation, as a key step in the clinical development of its HCV therapeutic, TT-034.
Synteract has extensive experience in conducting clinical trials and preparing regulatory submissions in the HCV field. The company has managed numerous projects across all phases of clinical development leading to twenty-two US FDA product approvals.
Synteract have begun work on the project implementation tasks under the direction of Benitec.
These activities include assistance in reviewing the clinical trial protocol and compilation of regulatory submissions.
Benitec plans to enter the clinic in 2013 with TT-034, a late-stage preclinical ddRNAi-based gene silencing molecule.
Benitec CEO Dr Peter French commented, “The Board and Management is very pleased to be working with Synteract. Synteract met the extensive criteria for the choice of CRO for our HCV clinical trial process, and we now look forward to progressing TT-034 into the clinic in 2013.”