Ruthigen enrolls first patient in Phase 1/2 clinical trial of RUT58-60

Nov 4 2014

Ruthigen, Inc. (NASDAQ: RTGN), announced today enrollment of the first patient in a Randomized, Double-Blind Phase 1/2 clinical trial to evaluate the safety, tolerability, and potential efficacy of its lead drug candidate, RUT58-60, for use as an adjunct to systemic antibiotics in abdominal surgery.

Ruthigen plans to enroll 150 patients in the Phase 1/2 trial, which will evaluate RUT58-60's safety, tolerability and potential efficacy for use as an adjunct to systemic antibiotics in patients undergoing abdominal surgery. The first 20 patients in the Phase 1/2 trial will be evaluated initially for safety by a Data Monitoring Committee and will also be included in the total patient population for potential efficacy. The patients will be divided into a control group that will receive the standard treatment of an intra-operative lavage with saline plus systemic antibiotics and a drug arm that will receive a RUT58-60 as an intra-operative lavage plus systemic antibiotics.

"Our medical community, government and society are heightened to the risks associated with antibiotic resistance, hospital acquired infectious and other infectious diseases. We are proud to be initiating this study to evaluate a potential novel approach to infection control associated with abdominal surgery," said Hoji Alimi, Ruthigen's CEO and chief scientific officer.