Ruthigen, Inc., (NASDAQ: RTGN) today announced that it has treated the first human subjects with its leading drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August 2014.
In June 2014, Ruthigen's Investigational New Drug (IND) application became effective following review by the U.S. Food and Drug Administration (FDA). Ruthigen is developing RUT58-60 as a safe and fast acting, broad spectrum and potent anti-infective drug candidate intended to be used as an adjunct therapy to systemic antibiotics for the prevention and treatment of infection associated with abdominal surgery.
"We are excited to begin a new chapter for Ruthigen with the initiation of human clinical testing of RUT58-60," said Hoji Alimi, Chairman, CEO and CSO of Ruthigen. "Treatment of our first subject with RUT58-60 is an important milestone and marks a transition for Ruthigen into a clinical-stage company." Mr. Alimi continued, "Patients undergoing abdominal surgery should not have to worry about the risk of infections associated with their procedures. At Ruthigen we believe the key to optimizing patient care is to focus on the prevention of infections in the hospital and outpatient surgical settings."
Following an independent data monitoring committee review, the Company plans to begin enrollment in a 150 patient, 28-day Phase 1/2 clinical trial using RUT58-60 within the abdominal cavity. The Phase 1/2 trial will be a controlled, double blind, randomized, and multi-centered study to evaluate the safety, tolerability, and potential efficacy of RUT58-60.