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May 2, 2014
07:12 EDTRTGNRuthigen submits IND application for clinical trial of RUT58-60
Ruthigen announced that the company has submitted an Investigational New Drug Application to the FDA for its lead drug candidate RUT58-60. The company plans to initiate its combined Phase 1/2 clinical trial for RUT58-60, entitled: "A Phase 1/2 Double Blind, Randomized Controlled Study to Evaluate the Safety and Efficacy of RUT58-60 Lavage Following Abdominal Surgery as an Adjunctive Therapy to Prophylactic Systemic Antibiotics," as early as July. Ruthigen has incorporated feedback from the FDA, received in connection with the Company's previously conducted pre-IND meeting, into the development program. The proposed Phase 1/2 trial design contemplates an initial enrollment of approximately 20 patients as part of a brief Phase 1 component of the study to establish the safety and tolerability of RUT58-60 in humans. The trial will remain blinded with the exception of the safety portion for the initial 20 patients. The Company plans to continue the enrollment of the remaining 130 patients in the clinical trial, subject to confirmation by the data monitoring committee of no significant adverse events.
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