Ruthigen begins Phase 1/2 clinical trial of RUT58-60

Oct 8 2014

Ruthigen Inc. (NASDAQ: RTGN), a biopharmaceutical company focused on pioneering new therapies to improve patient outcomes and reduce healthcare costs associated with infections related to post-operative invasive procedures, announces the initiation of a 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 has engaged principal investigators at four U.S. clinical trial sites: the University of Virginia Medical Center, Helen Keller Hospital in Sheffield, AL, the University of South Alabama Medical Center, and Memorial Hermann Memorial City Medical Center in Houston, TX. Patient screening has begun at these clinical trial sites and prescreening activities have begun at clinical sites that are in the final review process.

"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," said Hoji Alimi, Ruthigen's CEO and chief scientific officer. "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."

The Phase 1/2 clinical trial will be a controlled, randomized, double-blind and multi-centered trial. Initially, the Company will enroll 20 patients, who will be divided into a control group that will receive the standard treatment of a saline lavage and systemic antibiotics and a drug arm that will receive a RUT58-60 lavage and systemic antibiotics. Ruthigen plans to ultimately enroll 150 patients in the Phase I/II trial, which will evaluate RUT58-60's safety, tolerability and potential efficacy for use as an adjunct to systemic antibiotics in abdominal surgery.

SOURCE Ruthigen, Inc.