Ruthigen Gets FDA Clearance For Human Trial Of RUT58-60 For Infection Control

(RTTNews) - Biopharmaceutical company Ruthigen, Inc. (RTGN) Thursday said the U.S. Food and Drug Administration or FDA has cleared it's Investigational New Drug or IND application without a clinical hold to begin human clinical testing of RUT58-60 in the U.S.

RUT58-60, a new chemical formulation containing hypochlorous acid, was designed to improve infection control in surgical procedures.

The firm expects to enroll its first patient in July 2014 and complete a 30 patient, 21-day skin irritation trial in August 2014. Further, the company will conduct a Phase I/II study, involving 150 patients, to assess the safety, tolerability, and efficacy of RUT58-60 as an adjunct therapy to systemic antibiotics for the prevention of infection associated with abdominal surgery.

The initial 20 patient safety portion of the study is expected to be complete in the fourth quarter of 2014, while the final stage is expected to close in the first quarter of 2015.