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NovaBay Pharmaceuticals, Incorporated, a scientific stage biotechnology corporate developing its first-in-class, anti-infective Aganocidereg ; compounds for the native non-systemic remedy and avoidance of antibiotic-resistant contagions, today provided an update on its section two scientific trial for the employment of its lead compound, NVC-422, to prevent urinary catheter blockage and encrustation which is often a contributory 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 trial compares the utilisation of a catheter irrigation answer containing NVC-422 to the utilization of a saline irrigation, the most generally used option for treating UCBE. The trial layout is a crossover take a look at in which the affected person serves as his / her very own control. Patients will obtain either NVC-422 or saline answer for a 2-week length delivered every two days through catheter irrigation. After a 2-week “washout” period, the patients will then receive a treatment with the other answer to complete the crossover design.
NovaBay plans to chat approximately the segment 2 effects and the phase 3 examine protocol with the FDA and initiate a Phase 3 registration have a look at for UCBE in 2012. NovaBay plans to find approval for NVC-422 catheter irrigation solutions through a PMA route with the FDA Medical Devices division with the goal label claim to be “maintenance of catheter patency.” . Design of the prevailing study can be found at the following link : clinicaltrials press releases . Etiology of Urinary Catheter Blockage and Encrustation (UCBE) . Encrustation of catheters is a standard problem in the care of many patients undergoing long-term indwelling bladder catheterization. The difficulty derives from an an an an an infection by urease-producing bacteria, particularly Proteus mirabilis.
those organisms colonize catheters, generating biofilm communities inserted in a gel-like polysaccharide matrix. The common complication of UCBE is urinary tract infections. Based on quantitative consumer analysis conducted by NovaBay, the US Scale of the marketplace of permanently catheterized patients is conjectured to be up to 335,000 with roughly one in three chronically at the mercy of UCBEs.
. NovaBay is focusing its era on 4 distinct therapeutic spaces : dermatology, ophthalmology, urology and infirmary contagions. NovaBay has the definite benefit of being partnered with Galderma S.A. (Galderma), the quantity one dermatology corporate in the global . In ophthalmology, the objective is to improve an eye drop for conjunctivitis with Alcon Research Limited.
(ALCON), the world's number one ophthalmology company. In urology, NovaBay intends to cut back the incidence of urinary catheter blockage and encrustation (UCBE) and the related urine passage infections with an irrigation solution containing NVC-422. In medical institution infection, NovaBay is focused on the six-million-patient marketplace of continual non-healing wounds, such as pressure, venous stasis and diabetic ulcers with its proprietary anti-microbial solution, NeutroPhasereg [*SCO], that has won two 510K clearances from the food and Drug Administration. NovaBay is growing business chances for its Aganocide portfolio of anti-infectives in 4 particular healthcare markets : dermatology, ophthalmology, urology and infirmary infections. Each one of those marketplace segments contains one or extra signs that are poorly served or have no approved FDA remedies available, all with heavy cash doable. NovaBay's technique is to deal with these market opportunities both thru partnerships and collaborations or by building an internal organisation to strategically market its own products while appropriate from a commercial viewpoint.
NovaBay's commercialization plan for its Urology Business Unit is to retain commercial rights in the massive U.S. Market and license rights to Europe and the Pacific Rim / Pacific. . Development Pathway . In 2008, after extensive preclinical testing which confirmed NVC-422's capability to take care of catheter patency over extended periods, NovaBay entered into the urology healing arena with the filing of an IND with the Food and Drug Administration.
After IND clearance, NovaBay effectively concluded a 32-volunteer Phase one human trial that indicated the product was safe at the suggested dose. Upon a success finishing of this Phase 1 trial, NovaBay entered an exploratory Phase two study in patients with grim bacteriuria, or colonization of bladder with micro organism but not yet considered an evidential urine canal infection. The study confirmed clearly that NVC-422 was smartly put up with and reduced or eliminated certain pathogens in the piss. No serious unfavourable events have been reported. . For more information on the Phase 2 trial, seek advice from : novabaypharma . NovaBay's Aganocide compounds are novel, huge spectrum, fast-acting, man-made N-chlorinated antimicrobial molecules designed to mimic the body's defense in opposition to infection.
When applied to the location of an infection, these compounds maintain biological activities while demonstrating improved solution stability over naturally occurring N-chlorinated antimicrobe molecules. In July 2010, NovaBay declared 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 catching infection following 7 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 handled.
Additionally, Aganocide compounds have shown good in-vitro task against viruses and fungi and have the potential to ship 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 prescribed drugs is a clinical-stage biotechnology company targeted on growing its unique and patented Aganocide compounds. These are novel, synthesised anti-infectives with activity against bacteria, fungi and viruses, and are being developed to deal with and forestall a large range of local, non-systemic contagions with a low likelihood of developing bacterial resistance. NovaBay is focusing its technology on four distinct therapeutic areas : dermatology, ophthalmology, urology and hospital contagions.
In dermatology, the focal point is on developing NVC-422 gel for impetigo and acne. NovaBay has the transparent advantage of being partnered with Galderma, the number one dermatology company worldwide. In ophthalmology, the goal is to boost an eye drop for conjunctivitis with Alcon, the world's leading ophthalmology company. In urology, NovaBay aims to scale back the prevalence 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 persistent non-healing wounds,eg pressure, venous stasis and diabetic ulcers with its exclusive anti-microbe solution, NeutroPhasereg [*SCO], which has received two 510K clearances from the Food and Drug Administration. For detailed information, please visit novabaypharma.