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Glycosaminoglycans to Treat and Prevent Radiation Induced Oral Mucositis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DE024024-02A1
Agency Tracking Number: R44DE024024
Amount: $746,312.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCR
Solicitation Number: PA15-269
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Dover, DE 19904-7620
United States
DUNS: 827444345
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (507) 358-4465
Business Contact
Phone: (801) 649-3999
Research Institution

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

* Information listed above is at the time of submission. *

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