GLYCOMIRA, LLC — Department of Health and Human Services SBIR Phase II: NIDCR

Description

ABSTRACT Oral mucositis is a devastatingly painful inflammatory disease that frequently develops during cancer therapy and affects half a million people in the US The accompanying pain is so severe that patients often require narcotic pain medicines The clinical manifestations are ulcers in the mouth and gastrointestinal tract which are exacerbated by opportunistic infections Many patients also suffer from dry mouth causing difficulty in swallowing because of the decreased salivary gland function As a result these patients often need feeding tubes which interrupts their cancer treatment The financial burden to the patient is staggeringly high costing an additional $ to $ for each patient Preventing oral mucositis will therefore greatly enhance the cancer therapy as well as the wellness of the patients GlycoMiraandapos s lead candidate GM is a new class of anti inflammatory drugs The SBIR Phase I study results demonstrate its powerful anti inflammatory effects in a radiation induced oral mucositis animal model GM reduced tissue ulceration and inflammation in the tongue Histologically tongue tissues from the GM treated group showed markedly reduced infiltration of leukocytes with thicker mucosal layers and prevention of mucous glandular alterations compared to the tissues from vehicle treated animals Biochemical analyses also showed consistently lower leukocyte enzyme MPO activity as well as reduced concentration of nerve growth factor NGF in GM treatment groups In addition GM treatment prevented radiation induced alterations of the salivary glands Overall the data suggest that it is feasible to use GM to prevent oral mucositis The current SBIR Phase II application proposes to further develop GM as a viable and effective therapy for oral mucositis The objectives are to investigate the optimal dosing regimen in a radiation induced oral mucositis animal model determine the optimal formulation for topical delivery of GM in the oral mucosa validate the topical GM formulation in radiation and chemoradiation induced animal models and investigate the molecular targets of GM to reduce oral mucositis The results of the proposed research will lead to the delivery of a viable and effective therapy to the patients suffering from this devastating disease PROJECT NARRATIVE GlycoMira seeks to develop a simple mechanistically based treatment for oral mucositis a common and debilitating complication of cancer treatment Cancer patients undergoing radiation therapy develop painful severe ulcerations of the mouth that seriously degrade the patient s quality of life and compromise treatment and prognosis because their presence causes the physician to interrupt the course of cancer therapy