US-based biopharmaceutical firm Ruthigen has started a Phase I/II clinical trial of its lead drug candidate, RUT58-60, for use as an adjunct to systemic antibiotics in abdominal surgery.
RUT58-60 is a broad-spectrum anti-infective that the company is developing for the prevention and treatment of infection in surgical and trauma procedures.
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Initially, about 20 patients will be enrolled in the controlled, randomised, double-blind and multi-centred Phase I/II trial.
Ruthigen CEO and chief scientific officer Hoji Alimi said: "We are excited to be on pace to complete enrollment of our first 20 patients as planned in Q4 2014.
"Upon clearance from the Data Monitoring Committee, we expect to enroll the remaining 130 patients required to complete the Phase 2 portion of our trial by the end of Q1 2015.
"We expect to bring on additional clinical trial sites over the next 30 days. We plan to complete the full 150 patient enrollment in our Phase 1/2 trial by the end of Q1 2015."
These patients will be divided into a control group that will receive the standard treatment of a saline lavage and systemic antibiotics, while a drug arm will receive a RUT58-60 lavage and systemic antibiotics.
The Phase I/II trial will evaluate safety, tolerability and potential efficacy of RUT58-60.
The company has engaged principal investigators at four US clinical trial sites: the University of Virginia Medical Center, Helen Keller Hospital in Sheffield, the University of South Alabama Medical Center, and Memorial Hermann Memorial City Medical Center in Houston.
Patient screening has started at these clinical trial sites and pre-screening activities have begun at clinical sites that are in the final review process.
The company is focused on pioneering new therapies to improve patient outcomes as well as reduce healthcare costs associated with infections related to post-operative invasive procedures.
