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 solutions via a PMA route with the FDA Medical Devices division with the target label claim to be "maintenance of catheter patency."