Thursday, November 21, 2024
11/21/2024
DESCRIPTION (provided by applicant): Oral mucositis (OM) is one of the most common side effects of most anti-cancer therapies, affecting nearly 100% of head and neck cancer patients (5-6% of the 12.7 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 4 mouth rinses every 4 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 Materials' product to treat OM will be a drug-device combination composed of (1) a sachet containing a single dose of poly(curcumin) powder and, (2) a wide-mouth bottle containing 5 ml of mucoadhesive solution. In Phase I, we demonstrated that biodegradable microparticles of poly(curcumin) can provide a sustained release of curcumin for 24 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: 1. Optimize efficacy of poly(curcumin) oral rinse to treat radiation-induced OM. 2. Scale up manufacturing to produce pilot preclinical batch. 3. Develop combination product packaging in sachets and bottles and perform stability testing. 4. 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.
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