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SOURCE Ruthigen, Inc.
SANTA ROSA, Calif., June 12, 2014 /PRNewswire/ -- Ruthigen, Inc., (NASDAQ: RTGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, is pleased to announce today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application without a clinical hold to begin human clinical testing of RUT58-60.
Ruthigen expects to enroll its first patient in July 2014 and complete a 30 patient, 21-day skin irritation trial in August 2014. Following an independent data monitoring committee review, the Company plans to enroll 20 patients, as part of the Phase 1/2 trial, to evaluate the safety of the product within the abdominal cavity. The Phase I/II trial will be a controlled, double blind, randomized, and multi-centered study to evaluate the safety, tolerability, and efficacy of RUT58-60 as an adjunct therapy to systemic antibiotics for the prevention of infection associated with abdominal surgery.
The Company expects to enroll a total of 150 patients to complete the Phase 1/2 trial. The initial 20 patient safety portion of the Phase 1/2 trial is expected to be completed in Q4 2014. The trial will remain blinded; however, the safety results for the initial 20 patients will be reviewed by the data monitoring committee. 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. Ruthigen expects to complete the Phase 1/2 trial in Q1 2015.
Hoji Alimi, Chairman, CEO and CSO of Ruthigen, said: "We are excited to be in position to begin the clinical development of RUT58-60. Unlike the most commonly prescribed antibiotics, RUT58-60 is a broad and fast acting anti-infective with in vitro efficacy data against gram-positive and gram-negative bacteria including antibiotic resistant strains such as MRSA. RUT58-60 has a novel mechanism of action 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."
Ruthigen, whose fiscal year end is March 31, 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. 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.
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