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, today provided an update on its Phase 2 clinical trial for the use of its lead compound, NVC-422, to prevent urinary catheter blockage and encrustation (UCBE) which is often a contributing factor to urinary tract infections in chronically catheterized patients.
UCBE Clinical Pathway
With recruitment beginning in December 2010, NovaBay’s multi-center, randomized, double-blind proof-of-concept clinical trial compares the use of a catheter irrigation solution containing NVC-422 to the use of a saline irrigation, the most commonly used option for treating UCBE. The primary inclusion criterion is that subjects 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.
Primary Outcome Measures:
• Catheter patency following treatment
Secondary Outcome Measures:
Incidence of catheter blockage requiring early removal
Assessment of biofilm of catheter
Assessment of encrustation of catheter
NovaBay expects the trial to be completed in Q3 2011 with results available in Q4 2011. NovaBay plans to discuss the Phase 2 results and the Phase 3 study protocol with the FDA and initiate a Phase 3 registration study for UCBE in 2012. NovaBay plans to seek approval for NVC-422 catheter irrigation solution via a PMA route with the FDA Medical Devices division with the target label claim to be “maintenance of catheter patency.”
Design of the current study can be found at the following link: http://www.clinicaltrials.gov/ct2/show/NCT01243125?term=novabay&rank=2
Etiology of Urinary Catheter Blockage and Encrustation (UCBE)
Encrustation of catheters is a common complication in the care of many patients undergoing long-term indwelling bladder catheterization. The problem stems from infection by urease-producing bacteria, particularly Proteus mirabilis. These organisms colonize catheters, producing biofilm communities embedded in a gel-like polysaccharide matrix. The common complication of UCBE is urinary tract infection. Based on quantitative market research conducted by NovaBay, the US Market size of permanently catheterized patients is estimated to be up to 335,000 with approximately one-third chronically susceptible to UCBEs.
NovaBay’s Business Strategy
NovaBay is focusing its technology on 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 distinct advantage of being partnered with Galderma S.A. (Galderma), the leading dermatology company in the world. In ophthalmology, the goal is to develop an eye drop for conjunctivitis with Alcon Research Ltd. (Alcon), the world’s leading 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 510K clearances from the Food and Drug Administration.
NovaBay is developing commercial opportunities for its Aganocide portfolio of anti-infectives in four distinct healthcare markets: dermatology, ophthalmology, urology and hospital infections. Each of these market segments contains one or more indications that are poorly served or have no approved FDA treatments available, all with significant revenue potential. NovaBay’s strategy is to address these market opportunities either through partnerships and collaborations or by building an internal organization to strategically market its own products when appropriate from a commercial standpoint.
NovaBay’s commercialization strategy for its Urology Business Unit is to retain commercial rights in the large U.S. market and license rights to Europe and the Asia/Pacific.
In 2008, after extensive preclinical testing which confirmed NVC-422’s ability to maintain catheter patency over extended periods, NovaBay entered into the urology therapeutic arena with the filing of an IND with the Food and Drug Administration. After IND clearance, NovaBay successfully concluded a 32-volunteer Phase 1 human trial that indicated the product was safe at the proposed dose. Upon successful completion of this Phase 1 trial, NovaBay entered an exploratory Phase 2 study in patients with severe bacteriuria, or colonization of bladder with bacteria but not yet considered a symptomatic urinary tract infection. The study showed that NVC-422 was well tolerated and reduced or eliminated certain pathogens in the urine. No severe adverse events were reported.
For more information on the Phase 2 trial, visit: http://www.novabaypharma.com/investors/release/apr_15_2010
About NovaBay’s Aganocide Compounds
NovaBay’s Aganocide compounds are novel, broad-spectrum, fast-acting, synthetic N-chlorinated antimicrobial molecules designed to mimic the body’s defense against infection. When applied to the site of an infection, these compounds maintain biological activities while demonstrating improved solution stability over naturally occurring N-chlorinated antimicrobial molecules. In July 2010, NovaBay announced positive results in a 129-patient, Phase 2a impetigo skin infection study. The results showed 92% of the patients in NovaBay’s highest dose were cured of the highly contagious infection following seven days of treatment with NovaBay’s lead Aganocide compound (NVC-422) topical gel. Patients in the study infected with methicillin-resistant Staphylococcus aureus (MRSA) impetigo infection were successfully treated. Additionally, Aganocide compounds have shown good in-vitro activity against viruses and fungi and have the potential to deliver the same or better efficacy than antibiotics, and to address the growing problem of antibiotic resistance by employing a novel mechanism of action.
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 is focusing its technology on 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 distinct 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 leading 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 510K clearances from the Food and Drug Administration. 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, the use of NVC-422 solutions to control bacteria that inevitably and rapidly develop in urinary catheters and in the bladder represents a significant opportunity for NovaBay, that NovaBay expects the trial to be completed in Q32011, with results available in Q4 2011, that NovaBay plans to discuss the Phase 2 results and the Phase 3 study protocol with the FDA and initiate a Phase 3 registration study for UCBE in 2012, 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; the risk of unexpected delays in the regulatory process which may delay the commencement or completion of clinical trials and the risks that results obtained in the Phase I and exploratory Phase 2 may not be obtained in the current Phase 2 clinical trial. 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 Quarterly Report on Form 10-Q, under the caption “Risk Factors” in Item 1A of Part II of that report, which was filed with the Securities and Exchange Commission on November 12, 2010. 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 Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson
The Investor Relations Group