26.08.2014 13:33:52
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Ruthigen: DMC Recommends Initiation Of Phase 1/2 Trial For RUT58-60
(RTTNews) - Ruthigen Inc. (RTGN), a developer of drugs to prevent infection in invasive procedures, Tuesday said a data monitoring committee has recommended the company to begin enrolling patients in a Phase 1/2 clinical trial for its broad-spectrum anti-infection drug RUT58-60.
The recommendation follows a 21-day skin irritation study on 36 human participants completed in August. The next step is to conduct a randomized, double-blind and multi-centered trial, for which Ruthigen will start enrolling patients in September.
"Our team has been right on track in meeting the milestones of our clinical development program," said CEO Hoji Alimi. "If all goes according to plan, we expect to begin preparations for our first U.S. pivotal trial in mid to late 2015."
The company sees the drug, which is its lead candidate, as an adjunct therapy to prophylactic systemic antibiotics to prevent infections in abdominal surgical procedures. One of the advantages of RUT58-60, the company says, is that it may reduce the potential for emergence of antibiotic-resistant bacteria.
Ruthigen believes the investigational drug works by mimicking the body's natural microbe-fighting mechanisms.
For the Phase 1/2 trial, Ruthigen plans to enroll 150 patients with 20 patients enrolled initially.
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