Presentation Highlights the Efficacy of the Lead Aganocide Compound as a Potential Break-Through Treatment for Prevention of Urinary Catheter Blockage and Encrustation (UCBE) Often Leading to Infection
EMERYVILLE, Calif., April 12, 2011 (GLOBE NEWSWIRE) -- NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide® compounds for the local non-systemic treatment and prevention of antibiotic-resistant infections, presented a poster on the efficacy of its Aganocide compound as a potential agent for prevention and treatment for urinary catheter blockage and encrustation, often leading to urinary tract infections, at the 2011 conference of The Simon Foundation for Continence held in Chicago on April 12-13.
The poster, entitled "NVC-422 Prevents Urinary Catheter Blockage and Encrustation," notes that patients with long-term indwelling Foley catheters often face bacterial colonization resulting in encrustation and subsequent catheter blockage. The formation of a crystalline biofilm, most commonly triggered by the bacterium Proteus mirabilis, can lead to blockage of urine flow and incontinence, which in turn increases the risk of bacteriuria, pyelonephritis and in severe cases, septicemia.
NovaBay's research team created in vitro lab models of catheterized bladders that were filled with artificial urine and populated by the microorganism, P. mirabilis. Then, either NVC-422 or saline irrigation solution were delivered through the catheter every other day into the bladder chambers for up to 15 days or until the catheters became blocked by a crystalline biofilm. The formation of a biofilm, pH and bacterial counts in each case were carefully monitored.
The researchers found that the catheters irrigated with 0.2% solution of NVC-422 reduced P. mirabilis counts and lowered pH of urine after irrigation. Moreover, treatment with NVC-422 reduced the crystalline biofilm encrustation in this model and maintained catheter patency with the artificial urine being able to drain freely throughout the entire 15-day test period. However, the control catheters, treated with saline blocked on average approximately 58 hours after the start of the experiment. In the control group, crystalline biofilm was visually evident, urine pH increased significantly from 6 to 9, and high P. mirabilis cell counts were observed.
NovaBay is currently investigating NVC-422 irrigation solution in a double blind, randomized, placebo controlled, proof of concept clinical trial in one major spinal cord injury rehabilitation center and two Veterans Administration hospitals in the United States. The clinical study compares the every other day use of NVC-422 to saline irrigation solution which is the most commonly used option for treating UCBE. While saline solution may breakup the blockage and encrustation, the effect is temporary and the patients must undergo frequent irrigation multiple times per day. Saline does not address the underlying cause of the blockage which is often the urease producing Gram negative, P. mirabilis.
In this proof of concept clinical study, the primary inclusion criterion requires patients to have a history of chronic episodes of UCBE. The trial design is a crossover study in which the patient serves as his/her own control. Patients will receive either NVC-422 or saline solution for a 2-week period delivered every other day via catheter irrigation. After a 2-week "washout" period, the patients will then receive a treatment with the other solution to complete the crossover design. The aim of the study will be to enroll 20 patients and assess blockage and encrustation of their Foley catheters. More detail on this study can be found at:
http://www.novabaypharma.com/investors/release/March_02_2011
http://clinicaltrials.gov/ct2/show/NCT01243125?term=novabay&rank=2
Established in 2010, NovaBay's Urology Business Unit directs all activities relating to R&D, clinical development, commercialization plans in the United States and its global partnering activities. NovaBay expects this product to be marketed in 2014.
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"These positive in vitro results in NovaBay's proprietary biofilm model raise the profile of NVC-422 irrigation as a potent, fast-acting, broad-spectrum antimicrobial agent that can kill P. mirabilis and thereby inhibit the formation of struvite crystals in the catheter. These crystalline biofilms, if not treated, can result in the blockage of urine flow leading to urine leakage, painful distention of the patient's bladder, and can lead to pyelonephritis and septicemia. We are hopeful that this result will ultimately translate into the clinic for treating the estimated 100,000 patients who routinely suffer from severe catheter blockages and encrustation. Furthermore, based on NVC-422's mechanism of action, bacterial resistance is not expected," said Mark Anderson, PhD, NovaBay's Chief Scientific Officer and one of the poster's co-authors.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on developing its proprietary and patented Aganocide compounds. These are novel, synthetic anti-infectives with activity against bacteria, fungi and viruses, and are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance.
NovaBay has established four business units to develop and commercialize its technology in four distinct therapeutic areas: dermatology, ophthalmology, urology and hospital infections. In dermatology, the focus is on developing NVC-422 gel for impetigo and acne. NovaBay has the advantage of being partnered with Galderma, the leading dermatology company in the world. In ophthalmology, the goal is to develop an eye drop for conjunctivitis with Alcon, the world's foremost ophthalmology company. In urology, NovaBay aims to reduce the incidence of urinary catheter blockage and encrustation (UCBE) and the associated urinary tract infections with an irrigation solution containing NVC-422. In hospital infection, NovaBay is targeting the six-million-patient market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers with its proprietary antimicrobial solution, NeutroPhase®, which has received two 510(k) clearances from the Food and Drug Administration. For additional information, visit www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. The statements in this press release including, but not limited to, statements regarding NovaBay's expectations and potential regarding the potential of NVC-422 to treat urinary catheter blockage and encrustation and other infections, that the results of the in-vitro study on lab models of catheterized bladders that were filled with artificial urine and populated by P. mirabilis will translate into the clinic which is a significant opportunity for NovaBay; that NovaBay expects to market this product in 2014, as well as other statements that relate to future events or results, are 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 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: the risk that NovaBay may experience unexpected results in further studies which may limit, delay or prevent NovaBay from conducting further clinical trials; unexpected adverse side effects or inadequate therapeutic efficacy of NVC-422 may inhibit NVC-422 from becoming a treatment for urinary catheter blockage and encrustation; and the risk of unexpected delays in the regulatory process which may delay the commencement or completion of clinical trials. Other risks relating to NovaBay and its Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's Annual Report on Form 10-K for the period ended December 31, 2010, under the caption "Risk Factors" in Item 1A of Part I of that report, filed with the Securities and Exchange Commission on March 10, 2011. 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.