Validation of a novel, adjuvant implant for post-metastatic skeletal lesions

Project SummaryBone growth is critical to a favorable prognosis in thebreast cancer patients that have skeletal metastasesor approximatelypatients per year in the USLytic lesionsor voids in the boneresult from local bone destruction caused by tumor cell directedosteoclastic bone re absorption and lead to pathologic fracture and increased patient morbiditySurgical intervention is necessary to prevent initial fracture or other skeletal related eventsand involves stabilizing the defect created by the tumorCurrentlyfailure rates with these interventions arefor patients who survive more thanyear after fixation for pathological fractureBecause of the high failure rates and increased patient survivallytic lesions are affecting a growing patient population and account for approximately $billion in US healthcare expenditure per yearPatients with breast cancer bone metastasesi ea skeletal related eventrequire surgical intervention that stabilizes the tumor directed defect using intra medullar nailstotal joint prostheses and bone cementHoweverhardware and bone cement donandapos t promote bone formationGrowth factors have become a popular option to increase bone healinghoweverthese therapiessuch as BMPInfuseor PTHForteohave been given a black box warning by the FDA for patients with active tumor or patients who have been treated for tumorIn particularBMPhas been associated with increased tumor risk in patients who are undergoing Xradiation therapy or possess nascent undetected tumorIn response to this unmet needFusologicsLLCa New York based startup company is commercializing Naloventa novel surgical implant with demonstrated ability to treat lytic lesions by effectively growing bone and inhibiting local growth of cancer cellsBased on the discovery of a novel molecular pathway for bone growthNalovent induces osteogenesis via the local administration of an implant that contains the opioid antagonistnaloxoneembedded in a collagen delivery vehicleIf validatedNalovent would empower clinicians with a much needed solution to heal lytic lesions and fight residual tumor in order to deliver significantly improved outcomes to the large and growing population of breast cancer patients with skeletal metastasesThis proposal consists of two aimsoptimization of the Nalovent osteogenic implant around local inhibition of tumor growthandvalidation of the Nalovent implant in relevant in vivo studiesIf successfulthis proposal will demonstrate commercial proof of concept for the Nalovent implant and establish the foundation for a Phase II proposal to support remaining preclinical development in preparation for human trials Project NarrativeBone growth is critical to a favorable prognosis in thebreast cancer patients that have skeletal metastases orpatients per year in the USLytic lesionsor voids in the boneresult from local bone destruction caused by tumor cell directed osteoclastic bone re absorptionThese lesions do not heal well after therapywhich result in pathologic fracture and increased patient morbidityand require surgical fixation to stabilize the defectBecause current failure ratesre operationwith these surgical interventions arefor patients who survive more thanyear after fixation and due to increased patient survivallytic lesions are affecting a growing patient population and account for approximately $billion in US healthcare expenditure per yearIn response to this unmet needFusologicsLLCa New York based startup company is commercializing Naloventa novel surgical implant with demonstrated ability to treat lytic lesions by effectively growing bone and inhibiting local growth of cancer cells