More and more research universities are jumping into the CRO game, using their existing labs and expertise to launch moneymaking operations. Duke University is no different, and the school's clinical research unit has signed on with Benitec Biopharma to run Phase I/II trials for an RNAi hepatitis C drug.
The Duke Clinical Research Unit is on the hook to test the safety and effectiveness of Benitec's TT-034, an RNA interference treatment that works to silence the genes that allow the virus to thrive. Benitec touts it as a potential one-shot cure for HCV, as a single administration has shown promising results in ridding mice and monkeys of the virus.
The Phase I/II trial marks Australia's Benitec's transition into a clinical-stage company, and Duke lead investigator Keyur Patel said the company's candidate could transform the way HCV is treated.
"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," Patel said in a statement.
The trial will test TT-034 on 14 patients with chronic HCV genotype 1 infection who haven't benefited from previous treatments, looking for endpoints of limited adverse events and reduced viral load.
The Duke Clinical Research Unit has about 80 Phase I studies under its belt, and the outfit bills itself as the only university-based contractor that can provide all the services of a large CRO backed up with the academic credibility of a top-tier research institute.
- read the announcement
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