SANTA ROSA, Calif., Nov. 4, 2014 /PRNewswire/ -- Ruthigen, Inc. (NASDAQ: RTGN), announced today enrollment of the first patient in a Randomized, Double-Blind Phase 1/2 clinical trial to evaluate the safety, tolerability, and potential efficacy of its lead drug candidate, RUT58-60, for use as an adjunct to systemic antibiotics in abdominal surgery.
Ruthigen plans 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 patients undergoing abdominal surgery. The first 20 patients in the Phase 1/2 trial will be evaluated initially for safety by a Data Monitoring Committee and will also be included in the total patient population for potential efficacy. The patients will be divided into a control group that will receive the standard treatment of an intra-operative lavage with saline plus systemic antibiotics and a drug arm that will receive a RUT58-60 as an intra-operative lavage plus systemic antibiotics.
“Our medical community, government and society are heightened to the risks associated with antibiotic resistance, hospital acquired infectious and other infectious diseases. We are proud to be initiating this study to evaluate a potential novel approach to infection control associated with abdominal surgery,” said Hoji Alimi, Ruthigen’s CEO and chief scientific officer.
Additional information about the clinical trial, including trial locations, is available at www.clinicaltrials.gov.
About Ruthigen
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 addressable market for RUT58-60 is approximately 30 million surgical and trauma procedures that are performed annually in the United States. The company’s clinical program targets an initial $700 million potential market in the prevention of infections associated with abdominal surgery, with the market for the prevention of infections associated with all types of surgery being estimated at $3 billion. Ruthigen plans to complete its Phase 1/2 clinical trial in Q1 2015 and, pending the successful completion of that trial, to conduct pivotal clinical trials. For more information, visit www.ruthigen.com.
About RUT58-60
RUT58-60 is a broad-spectrum anti-infective drug candidate designed for prophylactic use during invasive surgical procedures. The new chemical formulation contains hypochlorous acid (HOCl) with no hypochlorite, and utilizes other small molecule stabilizers. The drug candidate 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 time. RUT58-60 was designed to improve patient lives, redefine infection control in surgical procedures and deliver cost savings to hospitals. RUT58-60 is proposed for use as an adjunct therapy in combination with prophylactic systemic antibiotics 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 is designed to be used in an intra-operative abdominal lavage -- a common procedure in invasive surgery -- it has the advantage of requiring no changes to surgeon or hospital procedures.
Forward-Looking Statements
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.
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