Ruthigen Initiates Phase 1/2 Clinical Trial Of RUT58-60
SANTA ROSA, Calif., Oct. 8, 2014 /PRNewswire/ -- Ruthigen Inc. (NASDAQ: RTGN), a biopharmaceutical company focused on pioneering new therapies to improve patient outcomes and reduce healthcare costs associated with infections related to post-operative invasive procedures, announces the initiation of a 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 has engaged principal investigators at four U.S. clinical trial sites: the University of Virginia Medical Center, Helen Keller Hospital in Sheffield, AL, the University of South Alabama Medical Center, and Memorial Hermann Memorial City Medical Center in Houston, TX. Patient screening has begun at these clinical trial sites and prescreening activities have begun at clinical sites that are in the final review process.
"We are excited to be on pace to complete enrollment of our first 20 patients as planned in Q4 2014. Upon clearance from the Data Monitoring Committee, we expect to enroll the remaining 130 patients required to complete the Phase 2 portion of our trial by the end of Q1 2015," said Hoji Alimi, Ruthigen's CEO and chief scientific officer. "We expect to bring on additional clinical trial sites over the next 30 days. We plan to complete the full 150 patient enrollment in our Phase 1/2 trial by the end of Q1 2015."
The Phase 1/2 clinical trial will be a controlled, randomized, double-blind and multi-centered trial. Initially, the Company will enroll 20 patients, who will be divided into a control group that will receive the standard treatment of a saline lavage and systemic antibiotics and a drug arm that will receive a RUT58-60 lavage and systemic antibiotics. Ruthigen plans to ultimately enroll 150 patients in the Phase I/II trial, which will evaluate RUT58-60's safety, tolerability and potential efficacy for use as an adjunct to systemic antibiotics in abdominal surgery.
More information about the trial, including trial locations, will be available by visiting www.clinicaltrials.gov.
About Ruthigen
Ruthigen is a biopharmaceutical company focused on pioneering new therapies to improve patient outcomes and reduce healthcare costs associated with infections related to post-operative invasive procedures. 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. Ruthigen plans to complete its Phase I/II 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. RUT58-60 is proposed for use as an adjunct therapy in combination with prophylactic systemic antibiotics in abdominal 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. RUT58-60 was designed to improve patient lives, redefine infection control in surgical procedures and deliver cost savings to hospitals. 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.
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.