Benitec adds fourth clinical site for one-dose trial of HCV drug

Benitec Biopharma Limited announced the addition of a fourth clinical site, Methodist Health System Clinical Research Institute in Dallas, Texas, for its ongoing phase 1 clinical trial of TT-034, a DNA directed RNA–interference-based therapeutic for treating hepatitis C virus infection, according to a press release.

TT-034 (Benitec) is designed to treat and cure HCV with a single-dose administration by targeting HCV RNA at three separate sites in the body, according to the release. It minimizes the ability of the virus to mutate and has the potential to also guard against re-infection without needing to undergo another dose. It is currently being investigated in an open-label dose escalation study in single doses among 14 patients with chronic HCV genotype 1 infection who have failed previous treatments.

Methodist Health System is the fourth site added for the clinical trial, joining Duke Clinical Research Institute, University of California San Diego and Texas Liver Institute. The release stated that the clinical site has already begun screening patients with HCV for the trial under the direction of Parvez S. Mantry, MD, medical director of the Liver Institute Research and medical director of the Hepatobiliary Tumor Program, Methodist Health System.

“We are pleased to welcome a fourth site to join our first-in-man trial of TT-034, an innovative therapeutic based on Benitec’s gene silencing technology, [DNA directed RNA interference],” Peter French, MBA, PhD, CEO and managing director of Benitec, said in the release. “The addition of this site reflects the growing interest from the medical community in Benitec’s potentially transformational approach to treating and curing hepatitis C. Recruitment and dosing for the trial is proceeding well.”

The Duke Clinical Research Unit of Duke Clinical Research Institute has been dosing individual patients with TT-034 since earlier this year. In May, the research team dosed the fifth and final patient in the phase 1/2a clinical study at their site.

Disclosures: French reports being employed by Benitec. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Mantry at the time of publication.