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SANTA ROSA, Calif., July 17, 2014 -- Ruthigen, Inc., (NASDAQ: RTGN) today announced that it has treated the first human subjects with its leading drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August 2014.
In June 2014, Ruthigen's Investigational New Drug (IND) application became effective following review by the U.S. Food and Drug Administration (FDA). Ruthigen is developing RUT58-60 as a safe and fast acting, broad spectrum and potent anti-infective drug candidate intended to be used as an adjunct therapy to systemic antibiotics for the prevention and treatment of infection associated with abdominal surgery.
"We are excited to begin a new chapter for Ruthigen with the initiation of human clinical testing of RUT58-60," said Hoji Alimi, Chairman, CEO and CSO of Ruthigen. "Treatment of our first subject with RUT58-60 is an important milestone and marks a transition for Ruthigen into a clinical-stage company." Mr. Alimi continued, "Patients undergoing abdominal surgery should not have to worry about the risk of infections associated with their procedures. At Ruthigen we believe the key to optimizing patient care is to focus on the prevention of infections in the hospital and outpatient surgical settings."
Following an independent data monitoring committee review, the Company plans to begin enrollment in a 150 patient, 28-day Phase 1/2 clinical trial using RUT58-60 within the abdominal cavity. The Phase 1/2 trial will be a controlled, double blind, randomized, and multi-centered study to evaluate the safety, tolerability, and potential efficacy of RUT58-60.
About Ruthigen, Inc.
Ruthigen is a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications. The Company's lead drug candidate, RUT58-60, is a broad-spectrum anti-infective that Ruthigen is developing for the prevention and treatment of infection in surgical and trauma procedures. The Company plans to complete its Phase I/II clinical trial in Q1 2015 and pending the successful completion of that trial, Ruthigen plans to conduct pivotal clinical trials. For more information, visit www.ruthigen.com.
RUT58-60 is a new chemical formulation containing hypochlorous acid, HOCl, with no hypochlorite, and utilizes other small molecule stabilizers. RUT58-60 is a broad-spectrum anti-infective drug candidate designed for prophylactic use during invasive surgical procedures. The drug has been shown in laboratory tests to eradicate both gram-positive and gram-negative bacteria, including antibiotic resistant bacteria within the first 30 seconds of contact. RUT58-60 was designed to improve patient lives, redefine infection control in surgical procedures and deliver cost savings to hospitals. RUT58-60 uses a mechanism of action designed to prevent emergence of bacterial resistance and improves patient safety by neither targeting specific bacterial cell membrane receptors nor exposing patient's vital organs to unnecessary systemic drugs. The Company's clinical program targets an initial $700M potential market in the prevention of infections associated with abdominal surgery. The Company believes the market for prevention of infection in the U.S. surgical market is estimated at $3B.
Except for historical information contained herein, this press release contains "forward-looking statements" (including, but not limited to, statements that contain words such as "will," "believe," "plan," "anticipate," "expect," "estimate") within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: our plans regarding our initial clinical trial, including the timing for initiation and completion, the proposed trial design, the principal investigator, phased enrollment and anticipated data; our plans regarding future clinical trials including potential pivotal trials, our understanding and beliefs regarding the anticipated benefits of our lead drug candidate RUT58-60 to patients and the healthcare system; and our beliefs as to the potential size of the target market for RUT58-60. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading "Risk Factors" contained in the documents filed by Ruthigen with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of the release, and Ruthigen disclaims any obligation to update the information contained in this press release as new information becomes available.
SOURCE Ruthigen, Inc.