BLUEGRASS ADVANCED MATERIALS, LLC — Department of Health and Human Services SBIR Phase II: NIDCR

Description

DESCRIPTION provided by applicant Oral mucositis OM is one of the most common side effects of most anti cancer therapies affecting nearly of head and neck cancer patients of the million new cancer cases worldwide annually OM manifests by deep and extremely painful mouth ulcers that can force patients to halt life saving anti cancer treatments and experience increased emergency room visits and longer hospital stays Lubricating and analgesic mouth rinses are the primary treatment options but provide only palliative care and have shown poor efficacy Palifermin recombinant keratinocyte growth factor is the only approved drug for treating OM in patients with hematological malignancies but is not approved for solid tumors and carries the risk of neoplasia Clearly an unmet need exists for effective and safe drugs to treat this condition Curcumin a multi action antioxidant and anti inflammatory compound derived from turmeric has been shown to reduce the incidence and severity of OM in preclinical studies and a recent human trial Unfortunately the trial required an aggressive dosing regimen of mouth rinses every hours likely due to the known poor bioavailability of curcumin Our innovation is a polymeric formulation that provides local and prolonged delivery of curcumin to buccal tissues which will increase its efficacy in treating OM Bluegrass Advanced Materialsandapos product to treat OM will be a drug device combination composed of a sachet containing a single dose of poly curcumin powder and a wide mouth bottle containing ml of mucoadhesive solution In Phase I we demonstrated that biodegradable microparticles of poly curcumin can provide a sustained release of curcumin for hours under physiological conditions while retaining antioxidant activity In a preclinical study we demonstrated that once daily treatment with a poly curcumin oral rinse reduced the severity of OM in the Syrian hamster model In Phase II we propose to Optimize efficacy of poly curcumin oral rinse to treat radiation induced OM Scale up manufacturing to produce pilot preclinical batch Develop combination product packaging in sachets and bottles and perform stability testing Demonstrate safety of poly curcumin oral rinse in GLP preclinical studies Successful completion of Phase II will accomplish the key tasks necessary to prepare for Phase I human clinical trials and enable us to approach the FDA to begin the approval process PUBLIC HEALTH RELEVANCE Oral mucositis OM is one of the most common side effects of most anti cancer therapies affecting nearly new cancer patients every year in the US OM which manifests as deep and extremely painful mouth ulcers forces patients to halt life saving anti cancer treatments and experience longer hospital stays Bluegrass Advanced Materialsandapos BAMandapos s product to treat OM is a combination device composed of a sustained release poly curcumin powder suspended in a viscous mucoadhesive solution which can be mixed quickly and rinsed in the mouth by patients The sustained and localized release of curcumin into the mouth tissue will target the key underlying mechanisms of OM oxidative stress Our product has the potential to greatly improve the quality of life of cancer patients