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NovaBay Pharmaceuticals, Incorporated, a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic cure and curbing of antibiotic-resistant contagions, presented a poster on the efficacy of its Aganocide compound as a potential agent for prevention and treatment for urinary catheter blockage and encrustation, habitually leading to urinary tract contagions, at the 2011 conference of The Simon Starting point for Continence held in Chicago on April 12-13. The formation of a crystalline biofilm, most widely caused by the micro-organism Proteus mirabilis, can lead to blocking of pee flow and incontinence, which increases the chance of bacteriuria, pyelonephritis and in dreadful cases, septicemia. . NovaBay’s research team created in vitro lab models of catheterized bladders that were filled with synthesised pee and populated by the microorganism, P. Mirabilis.
Then, either NVC-422 or saline irrigation solution were delivered through the catheter each alternative 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 scrupulously monitored. The researchers revealed that the catheters irrigated with 0.2% solution of NVC-422 reduced P. Mirabilis counts and decreased pH of piss after irrigation. However, the control catheters, treated with saline blocked on average roughly 58 hours after the begin of the experiment.
In the control group, crystal biofilm was visually clear, pee pH increased noticeably from 6 to nine, and high P. Mirabilis cell counts were noted. . NovaBay is at present investigating NVC-422 irrigation solution in a double blind, randomized, placebo controlled, evidence of concept medical test in one major spinal cord injury rehab center and 2 Vets Administration surgeries in the United States.
The clinical learn about compares the every second 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 repeating irrigation many times every day. Saline does not address the base cause of the blockage which is frequently the urease manufacturing Gram negative, P. Mirabilis. In this proof of idea clinical study, the main inclusion criterion requires patients to have a record of persistent 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 two days thru catheter irrigation. After a 2-week “disaster” period, the patients will then receive therapy with the alternative answer to finish the crossover design.
The purpose of the study will be to enroll twenty patients and evaluate blockage and encrustation of their Foley catheters. More detail on this report can be discovered at : . novabaypharma distribution exhort release . clinicaltrials . Established in 2010, NovaBay’s Urology Business Unit directs all activities relating to R&D, clinical development, commercial exploitation plans in the US and its world partnering activities. NovaBay expects this product to be sold in 2014. Mirabilis and so suppress the formation of struvite crystals in the catheter.
These crystal-like biofilms, if not treated, may end up in the clogging of urine flow leading to pee leaking, distressing distention of the patient’s bladder, and can cause pyelonephritis and septicemia. We are hopeful this result will ultimately transliterate into the hospital for treating the estimated 100,000 patients who routinely suffer from severe catheter blockages and encrustation. These are novel, synthesised anti-infectives with activity against bacteria, fungi and viruses, and are being developed to alleviate and stop a wide range of local, non-systemic contagions with a low likelihood of developing bacterial resistance. NovaBay has established 4 business units to develop and exploit commercially its technology in 4 distinct therapeutic areas : dermatology, ophthalmology, urology and surgery infections. In dermatology, the focus is on developing NVC-422 gel for impetigo and acne. NovaBay has the benefit of being partnered with Galderma, the leading dermatology company on the planet.
In ophthalmology, the goal is to develop an eye drop for conjunctivitis with Alcon, the planet's foremost ophthalmology company. In urology, NovaBay intends to diminish the incidence of urinary catheter blockage and encrustation (UCBE) and the associated urine canal illnesses with an irrigation solution containing NVC-422. In hospital infection, NovaBay is targeting the six-million-patient market of protracted non-healing injuries,eg pressure, venous stasis and diabetic ulcers with its proprietary anti-microbe solution, NeutroPhase (R), that has received two 510 (k) clearances from the Food and Drug Administration. For extra info, visit novabaypharma.