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Development of a novel small molecule-based approach for accelerated fracture repair in the aging skeleton

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AR076882-01
Agency Tracking Number: R44AR076882
Amount: $728,311.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAMS
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-13
Award End Date (Contract End Date): 2021-08-31
Small Business Information
1180 E ELLSWORTH RD, Ann Arbor, MI, 48108-2419
DUNS: 030776314
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (734) 975-3986
Business Contact
Phone: (734) 975-3839
Research Institution
PROJECT SUMMARY ABSTRACT Approximatelymillion fractures occur in the United States each yearaccounting forof all musculoskeletal injuries and leading to well overmillion hospital and physician offices visitsUp toof fractures are recalcitrant and require surgical intervention for proper healingThe weakened bones in the growing geriatric population are contributing to the rising number of cases of this orthopedic problem and are projected to fuel demand for newinnovative solutionsAccording to the Department of Economic and Social AffairsUnited NationsPopulation Divisionthe number of people aged overwasmillion inand is expected to reachbillion inThusthe market is anticipated to witness a significant demand in coming decadesCayman Chemical CompanyIncseeks to address the unmet need by developing and commercializing a new small molecule based locally administered drug matrix combination for at risk elderly fracture patients with delayed or nonunion fracturesDNFsCayman had discovered and patented a series of EPreceptor agonists designedsynthesizedand screened for target potency and selectivitycell activityand metabolic and physicochemical properties amenable to rapid systemic clearance suitable for local administrationDuring Phase I of this projectCayman selected the lead compoundKMNthat demonstrated osteogenic capacity in vitro and will serve as the active pharmaceutical ingredientAPIin the combination productAn osteoconductive mineralized collagen matrixMCMwas functionalized with multiple doses of KMNand the combination was evaluated in an accepted young rat femoral critical size defect model of nonunion fracturedemonstrating dose dependent efficacyDuring Phase IICayman will demonstrate dose dependent efficacy of the combination in a model comparable to that used in the pilot study using young and old rats from the NIA rodent colonyCayman will also initiate cGMP development of the API manufacture processwith which it will produce the release API batch that will be used for a GLP compliant pivotal rabbit studyCayman will combine the released API with a commercialkapproved MCM and demonstrate efficacy and safety in the GLP rabbit study PROJECT NARRATIVE Recalcitrant fractures in the growing aging population represents an increasing societal and economic burdenTo address this unmet needCayman Chemical CompanyIncwill develop the active pharmaceutical ingredientAPIof a drug device combination that accelerates fracture healing in elderly patients not likely to heal with existing intervention techniques

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

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