NovaBay's Lead Aganocide Compound, NVC-422, Well Tolerated in the Bladder in Phase I Trial
In this trial, designed to evaluate the safety of a prototype NVC-422 solution in the bladder, there were no serious adverse events and the number and nature of adverse events collected was not significantly different between the treated groups and those on placebo. The study involved two phases. In the first phase, cohorts of catheterized volunteers were given single doses of escalating concentrations of NVC-422 until the maximum planned dose was reached. In the second phase, catheterized volunteers participated in a double-blind placebo controlled one week study where they were administered the highest planned concentration of NVC-422 once daily. This study was designed to evaluate the safety and tolerability of NVC-422 in the bladder.
"We were very pleased to see that NVC-422 was tolerated in the human bladder at the highest dose planned. It is well known that the bladder is more sensitive than most organs to many small molecules, so with these positive results, we are now able to plan our Phase II clinical program which is likely to involve several exploratory studies that are designed to enable us to optimize the regimen for the product," said Dr. Behzad Khosrovi, NovaBay's Vice-President of Research and Development.
Professor Bernard Churchill, Vice Chairman of the Department of Urology at UCLA and a member of NovaBay's Scientific Advisory Board said, "It is very encouraging to see successful initial steps in the clinical testing of a new approach to the prevention, and the possible treatment, of urinary tract infections in catheterized patients. From the perspective of a urological surgeon, catheter associated urinary tract infections are a major problem that we face every day. With growing levels of bacterial resistance to the antibiotics on which we used to rely, there is an urgent need for new non-antibiotic products."
Catheter associated urinary tract infections are the most common type of infection found in hospitals and long-term care institutions, with some reports putting the number as high as 1,000,000 cases per year. CAUTI accounts for 40% of all nosocomial (hospital) infections. When a urinary tract infection develops, there is the possibility of it progressing to become a serious and even life-threatening bloodstream infection. The use of urinary catheters is a routine part of the management of patients in hospitals and often of persons in long-term care facilities. However, the catheter provides a means of access for bacteria to the bladder. They rapidly form bacterial biofilm on the catheter and cause bacteriuria, which is a condition in which bacteria grow within the bladder without giving rise to symptoms, but may lead to serious medical complications. Typically, approximately 5% of catheterized patients per day develop bacteriuria. After a patient has been catheterized for a month, it is virtually certain that the patient will have bacteriuria. If the patient progresses to a urinary tract infection, physicians are faced with an increasing problem of resistant bacteria. According to the Centers for Disease Control, several recent studies have shown that prophylactic systemic antibiotics delay the emergence of catheter-related infection, but this protective effect was transient and was associated with the selection of antibiotic-resistant microorganisms.
About the Aganocide Compounds
The Aganocide compounds are proprietary novel molecules developed by NovaBay and are designed to mimic the same antimicrobial action as the small molecules produced naturally by white blood cells. The naturally produced molecules are highly effective against all bacteria, viruses and fungi, but are produced and used by the body "on demand" and do not have the chemical stability to permit their use as pharmaceutical products. In laboratory testing, the Aganocide molecules maintain the efficacy and safety of the natural molecules but are stable, enabling their potential use as potent antimicrobial products.
NVC-422 is the lead Aganocide compound and has been shown to be safe at intended doses in a number of potential areas of use. It is N,N-dichlorodimethyltaurine, a close but stable analog of N,N-dichlorotaurine, the natural molecule produced by the human immune system,. In addition to development being conducted by NovaBay in nasal decolonization, urinary tract infections and dermatology, this compound is also being developed by Alcon, Inc. under a collaborative research and development agreement, for infections of the eye and ear. Alcon has also rights to use NVC-422 in the treatment of sinus infections.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and non-hospital environments. NovaBay has discovered and is developing a class of non-antibiotic anti-infective compounds, which it has named Aganocide compounds, which are based upon small molecules that are generated by white blood cells that defend the body against invading pathogens. NovaBay believes that Aganocide compounds could form a platform on which to create a variety of products to address differing needs in the treatment and prevention of bacterial and viral infections, including resistant bacteria such as MRSA. NovaBay has entered into a licensing and research collaboration agreement with an affiliate of Alcon, Inc. for use of the Aganocide compounds in the eye, ear and sinus, and in contact lens solutions. The company also has a license agreement with an affiliate of Kinetic Concepts, Inc. for the use of NovaBay's NeutroPhase product in woundcare applications.
NovaBay(TM), Aganocide(R), AgaNase(TM), and NeutroPhase(TM) are trademarks of NovaBay Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners.
This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the development and potential benefits of, and the market opportunities for, NovaBay's product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in discovery, development, testing, regulatory approval, production and marketing of the company's product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company's intellectual property or trade secrets, the company's ability to obtain additional financing as necessary and unanticipated research and development and other costs. The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
NovaBay Pharmaceuticals, Inc.
Theresa Granados, 510-899-8870
Manager, Investor Relations
The Investor Relations Group
Adam Holdsworth / Rachel Colgate / Erica Ruderman
Janet Vasquez / Laura Colontrelle
Posted: May 2008