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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

SANTA ROSA, Calif., Aug. 26, 2014 /PRNewswire/ -- Ruthigen Inc. (NASDAQ: RTGN), a biopharmaceutical company focused on improving patient outcomes and reducing healthcare costs in invasive procedures, has announced that its lead drug candidate, RUT58-60, has received a recommendation from the Data Monitoring Committee (DMC) to begin enrolling patients in the Company's planned Phase 1/2 clinical trial.

RUT58-60 is intended for use as an adjunct therapy in combination with prophylactic systemic antibiotics to prevent infections in abdominal surgical procedures. RUT58-60 is designed to improve patient outcomes, cut costs associated with hospital-acquired infections and reduce the emergence of harmful antibiotic-resistant bacteria. Because it can be used in a lavage -- a commonly performed cleansing procedure in invasive surgery -- it has the advantage of requiring no disruptions to surgeon or hospital procedures.

The DMC's recommendation followed a review of data from Ruthigen's first human clinical study of RUT58-60, a 21-day skin irritation study on 36 healthy subjects, which was completed in August 2014. The DMC's recommendation along with the incorporation of comments from FDA's previously completed IND review allows Ruthigen to proceed to the next phase of its clinical plan: a controlled, randomized, double-blind and multi-centered trial in which it expects to begin enrolling patients in September 2014.

"We are very excited to begin patient enrollment in our combined Phase 1/2 human clinical trial of RUT58-60," said Hoji Alimi, Ruthigen's CEO and chief scientific officer. "Our team has been right on track in meeting the milestones of our clinical development program. If all goes according to plan, we expect to begin preparations for our first U.S. pivotal trial in mid to late 2015."

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