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Ruthigen Receives Recommendation from Data Monitoring Committee to Initiate Phase 1/2 Human Clinical Trial of RUT58-60
Date:8/26/2014

lans 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 abdominal surgery. 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 expects to complete the initial 20-patient safety portion of the trial in late 2014. Once the DMC has reviewed the safety results and issued its recommendation to proceed, Ruthigen will continue with the enrollment of the remaining 130 patients. The Company expects to complete the Phase 1/2 trial in late first quarter of 2015. 

"We believe RUT58-60 has great potential for reducing infection in all types of invasive surgery," Mr. Alimi said. "We are beginning with abdominal surgery because it represents such a huge unmet need. Ultimately we plan to develop formulations of RUT58-60 for use in orthopedic, cardiovascular, spinal and other types of invasive surgery."

Unlike most commonly prescribed antibiotics, RUT58-60 is a broad and fast-acting anti-infective that has been demonstrated in-vitro to be effective against gram-positive and gram-negative bacteria, including antibiotic-resistant strains such as MRSA. The investigational drug, which is designed for prophylactic use to prevent infections in surgical and trauma procedures, is believed to work by mimicking the body's natural microbe-fighting mechanisms.

RUT58-60 is also expected to help keep healthcare costs down by reducing hospital readmission rates due to reinfection. Under the Affordable Care Act, hospitals are subject to financial penalties for patient readmissions. The drug also helps reduce healthcare costs by preventing infection in general, which leads to shorter stays and reduced costs for antibiotic treatmen
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