Novosteo Inc. — Department of Health and Human Services SBIR Phase I: NIDCR

Description

Project Summary Abstract SignificanceThe failure of bone fractures to adequately repair in elderly patients causes significant morbidity and mortality each year in the United StatesThis problem will continue to be exacerbated by an aging populationwith aincrease in hip fractures alone expected byand significant costs in lost workquality of lifephysical therapyextended care facility staysand surgeriesConventional therapy includes mechanically stabilizing the fracturebut thus farno systemic bone anabolic therapies exist to target and accelerate fracture repairPreliminary DataNovosteo Inchas developed a fracture targeted therapeutic that has demonstrated a dramatic acceleration in healing time and callus formation and remarkable specificity to bone fracture sitesAdministered systemically through subcutaneous injectionthe drug selectively accumulates on hydroxyapatitethe inorganic portion of bone exposed in a fractureproviding a site specific dose of anabolic agentThe targeted specificity to the fracture callus limits accumulation of the drug in off target tissuesreducing the potential for side effectsAlsothe systemic delivery route allows for multiple doses of anabolic agent to be administered rather than a single bolus possible via surgeryWhile bypassing the invasiveness of surgerythe drug mimics a locallyadministered anabolic in that drug accumulation is limited to the fracture site and sufficient dose can be administered for accelerated healingThus farNovosteoandapos s biodistribution studies have demonstrated no detectable toxicities at doses that dramatically accelerate fracture repairProposalThe overall goal of this Fast Track SBIR proposal will be to prepare the proposed fracture targeted therapy for clinical trialsThe first step will be to optimize the chemistry of Novosteoandapos s lead candidateThis will be accomplished in Phase I by performing the followingoptimization of the fracture targeting ligand composition andconducting a thorough analysis of the fracture targeted drugandapos s toxicityPhase II will focus on preparing the fracture targeted drug for INDThis will be accomplished byvalidating Phase I results in a non rodent modelconducting MTDGLP pharmacokineticsand GLP toxicity studiesandconducting genotoxicity analysis to evaluate any morphogenic dangersConclusionThe ability to accelerate bone fracture repair is a fundamental need that has not been addressed by conventional methodsIf grantedthe completion of the proposed studies would enable the optimization and pre clinical evaluation of an indispensable therapy for bone fracture repairIts safety and efficacy could then be explored and evaluated in other settings where accelerated bone regeneration is desiredsuch as hairline vertebral fractures in osteoporosis patients or craniofacial reconstruction and repair Project Narrative Accelerating fracture healing is an important economic and ethical problem that needs to be addressedNovosteo Incwill meet this need by developing the first targeted bone anabolic agent that will concentrate on a bone fracture surface following systemic administrationThis bone fracture therapy will help to save liveslimit fracture associated morbiditiesand reduce costs