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A Novel Glycosaminoglycan-Based Therapeutic for Chronic Rhinosinusitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI126987-01
Agency Tracking Number: R43AI126987
Amount: $297,614.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA15-269
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-08-01
Award End Date (Contract End Date): 2018-02-05
Small Business Information
Dover, DE 19904-7620
United States
DUNS: 827444345
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (434) 249-3268
Business Contact
Phone: (801) 649-3999
Research Institution

This proposal aims to develop a therapeutic capable of preventing and treating the severe sinus inflammation
associated with chronic rhinosinusitis CRS CRS is a debilitating inflammatory disease of the sinuses that
impacts over million Americans and substantially diminishes the quality of life and productivity of affected
patients From to the total US health care expenditure to treat patients with CRS increased from $
to $ billion USD with a corresponding rise in surgical treatment for those patients who fail current medical
management CRS is characterized by massive inflammatory cell infiltration and increased cytokine chemokine
production Therapy development should therefore be focused on inhibiting the mechanisms underlying the
initiation of these inflammatory responses with the ability to be delivered efficiently by high volume saline
irrigation known to improve mucosal penetration GlycoMira Therapeutics Inc GMTI is developing a
glycosaminoglycan based anti inflammatory compound GM for CRS that is polyanionic giving it
excellent solubility in saline Our work has shown that GM is safe efficiently penetrates the sinuses and
effectively prevents acute sinus inflammation by blocking neutrophil activation and mast cell infiltration into the
sinus mucosa GM additionally inhibits important early pro inflammatory signaling molecules such as
Toll like receptors and selectins resulting in decreased inflammatory mediator production Based on our
findings we hypothesize that GM can prevent the development and progression of CRS by inhibiting
inflammatory cell chemotaxis and activation within the sinuses thereby reducing inflammation Chemokines
RANTES and eotaxin are elevated in patients with CRS and are important in recruiting mast cells early
effector cells and eosinophils late effector cells which favor a therapeutic resistant state of inflammation We
will first test our hypothesis Aim by determining whether GM can inhibit chemokine mediated
activation of human mast cells eosinophilic cells and chemokine receptor knockdown cells negative control
measuring intracellular calcium flux proliferation and chemotaxis in the absence and presence of recombinant
chemokine These studies will provide inflammatory mechanism focused results for therapy translation to CRS
We will then test the feasibility of GM to prevent and treat CRS in vivo using a mouse model of CRS Aim
Applying two dosing regimens we will approach this goal by administering GM prior to and
after establishing chronic sinus inflammation Sinus tissues will be examined for histological characteristics
inflammatory cell infiltration secretory cell hyperplasia mucous secretion and mucosa thickening and tissue
inflammatory biomarkers mast cell tryptase eosinophil myeloperoxidase RANTES and eotaxin These
studies will provide crucial preclinical data supporting GM as a therapeutic aimed at preventing and
treating sinus inflammation in patients with CRS moving towards commercialization in a market with
tremendous unmet needs to improve the lives of millions of Americans PROJECT NARRATIVE
Chronic rhinosinusitius CRS is a debilitating disease of sinus inflammation that substantially diminishes the
quality of life and productivity of over million Americans resulting in an annual economic burden of $
billion USD The currently available therapies for CRS fail to control the inflammation in of every patients
leaving surgery as the alternative treatment We have developed a compound that efficiently coats the sinuses
and effectively inhibits multiple inflammatory events and factors underlying the mechanisms that favor
inflammation Having important implications for patients physicians and public policymakers alike we will
develop this compound into a therapeutic that is capable of preventing and treating CRS improving the lives of
millions of Americans

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

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