NovaBay Pharmaceuticals Announces Presentation of Positive Data From Its Clinical Trial of Auriclosene Irrigation Solution For Urinary Catheter Encrustation and Blockage

By May 21, 2014

NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biopharmaceutical company developing non-antibiotic, topical antimicrobial products, today announced that Todd  A. Linsenmeyer, M.D., Director of Urology, Kessler Institute for Rehabilitation, West Orange, NJ, and one of the principal investigators of a multi-center clinical study, will present results showing significant benefits from a new catheter irrigation solution. In the trial, 9 of 14 catheters collected from patients that irrigated twice a week with saline solution, the only current treatment option, became completely encrusted. In contrast, none of those treated with a new investigational product called Auriclosene Irrigation Solution (AIS) became significantly encrusted. Parallel reductions were seen in clinical catheter blockages.

Dr. Linsenmeyer will describe the Phase 2 trial and its results at the annual meeting of the American Urological Association meeting, May 16-21 in Orlando, FL—the first time the data have been presented at a scientific meeting.

The results represent a potentially significant step forward in the care of patients who must use urinary catheters that stay in place for days or weeks at a time—so-called indwelling catheters. Because of spinal cord injuries, multiple sclerosis, and other conditions, tens of thousands of people in the U.S. must use such catheters. The problem is that in some patients the catheter can frequently become coated with bacteria and crystalline biofilms, which can sometimes block the catheter entirely. Blockage of the catheter can cause very serious medical issues.

“The severe consequences of urinary catheter blockage and encrustation are often underappreciated,” Dr. Ron Najafi, Chairman and CEO of NovaBay Pharmaceuticals explained. “Catheter blockage can result not only in urinary tract infections and kidney infections, but also potentially life-threatening autonomic dysreflexia in those with high-level spinal cord injuries.” Autonomic dysreflexia is a sudden severe elevation in blood pressure that can lead to serious cardiovascular consequences if not taken care of immediately.

Doctors have tried to prevent catheter encrustation and blockages by irrigating catheters frequently with saline solution or regularly changing the catheters every week or two. Neither approach seems to solve the problem. That is why Dr. Linsenmeyer agreed to be a principal investigator in a trial of auriclosene, a stable version of potent natural anti-microbial substances that white blood cells use as a first defense against microbial invaders.

In the NovaBay clinical trial, 14 patients had their chronic indwelling urinary catheters irrigated either with auriclosene or saline solution two or three times a week for two or four weeks. After a washout period, those who had received auriclosene were switched to saline, and vice versa.

The results showed a highly significant benefit. Catheters irrigated with auriclosene were, on average, 55% less encrusted than those receiving saline. None treated with auriclosene became blocked, unlike the majority of those irrigated with saline.

Auriclosene and the Management of Urinary Catheter Encrustation
Encrustation of indwelling catheters results from the build-up of calcium and magnesium crystals in the lumen and inlet of catheters, which is caused by gram-negative bacteria that secrete an enzyme called urease.The condition requires catheters to be changed frequently. It can also lead to urinary tract infections (UTIs), kidney infections, incontinence due to the leakage of urine around the outside of clogged catheters and, in certain patients, severe and life-threatening episodes of uncontrolled autonomic dysreflexia. Autonomic dysreflexia (AD) is a reaction of the autonomic (involuntary) nervous system to noxious stimuli that occurs in individuals with high level spinal cord injuries. It may result in a number of problems such as profuse sweating, flushing and an intense, pounding headache. However, the most dangerous problem is a sudden severe increase in blood pressure. The most frequent causes of AD in those with an indwelling catheter are bladder over distention and catheter blockage. The AD continues until the blocked catheter is changed. If blockage is not dealt with immediately, the increased blood pressure could lead to a life-threatening stroke or cardiovascular event.

About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on addressing the unmet therapeutic needs of the global, topical anti-infective market with its Aganocide® compounds, led by auriclosene. Auriclosene is a new chemical entity invented by NovaBay and has a broad spectrum of activity against bacteria, viruses and fungi. Aganocide compounds are based on the human body’s natural immune system and the molecules involved in combating infections. Bacterial resistance to Aganocides is highly unlikely, as demonstrated in in vitro studies. Once pathogens penetrate the body’s primary defense, the next line of defense is provided by the white blood cells. NovaBay has focused on understanding these molecules generated by the white blood cells and finding ways, by chemical modification, to allow them to be developed as therapeutic products with the potential to treat a wide range of local, non-systemic infections. NovaBay believes that if Aganocides begin to supplement and thereby reduce the usage of classic topical antibiotics, they will help slow the rise of antibiotic resistance.

Forward-Looking Statements
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 expected timing of enrollment and commencement of clinical trials, expected timing of announcement of results of clinical studies, and expected future financial results. The words “continued,” “expected,” “will be,” “believe”, “expect”, “anticipate”, “would,” “planning” and other words (and all variations of these words that imply future events), identify these statements as forward looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different 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 development, clinical trial, 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. These risks and others are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” 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.

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NovaBay Pharmaceuticals Contacts
Thomas J. Paulson  
Chief Financial Officer
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Ana Kapor
Director, Investor Relations and Corporate Communications
NovaBay Pharmaceuticals, Inc.
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