March 22, 2013 – Duke’s Keyur Patel, MD will act as principal investigator for this trial, which will likely begin enrolling patients during the second half of 2013.
In a press release yesterday Australian RNAi-based therapeutics company Benitec Biopharma Limited announced it has selected the Duke Clinical Research Unit as a site for its upcoming phase I/II first-in-man trial for TT-034. Developed using Benitec’s ddRNAi (DNA-directed RNA interface) technology, TT-034 contains three separate RNAi elements targeted against the Hepatitis C (HCV) virus. This treatment is being developed as a potential “one-shot-cure” for HCV.
The phase I/II clinical trial will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. It is expected that the trial will include 14 patients in 5 sequential dose cohorts. The trial will likely begin enrolling patients during the second half of 2013.
Keyur Patel, MD, Duke’s principal investigator for the study, was selected because of his direct experience in using gene therapy to treat the HCV virus. Patel is also a recipient of the prestigious American Association for the Study of Liver Diseases (AASLD) Shelia Sherlock Clinical and Translational Research award and has over 100 citations in peer-reviewed publications.
“TT-034 is a potentially transformative new treatment,” Patel commented. “A therapeutic that could cure an HCV patient with a single injection would obviously be a big step forward compared to even the best treatments that are currently on the horizon, as they all involve comparatively lengthy regimens with a combination of several drugs.”