Alzeca Biosciences — Department of Health and Human Services SBIR Phase II: NIA

Description

Project SummaryAlzheimer s diseaseADis the most common form of dementiaaffecting roughlymillion Americansand is the sixth leading cause of death in the United StatesQuantification of amyloidAplaque burden withF andCbased Positron Emission TomographyPETimaging agentsbased on high affinity Aaggregate binding radionuclides shows promise for identifying individuals with increased risk of progressing to ADHoweverPET imaging has several drawbacks including high costlimited accessand poor spatial resolutionFurthermorePET involves radiochemistrywhich is both expensive and complexthereby limiting distribution potential to specialized medical centers with radiochemistry capabilitiesThis Phase II project will seek to further developADx Magnetic Resonance MRa targeted liposomal contrast agent that will be used in conjunction withT MR imaging systemswhich are far more readily available than PET imaging systemsand much less expensive to useThe primary objectives of this Phase II grant is to gather safety pharmacokinetic data in both small and large animalsand to transfer the synthesis process to a contract manufacturer in preparation for future GLP studiesADx MR has the potential to provide imaging of AD pathology at high resolutionand a significantly lower costwithx more patient access pointsthan PET amyloid imagingCoupled with the exceptional spatial resolution of MR Imagingthis agent enables the visualization of features at a voxel size ofma significant improvement over PET approaches with centimeter size voxelsTo datethis novelintravenously delivered Atargeted liposomeADxhas proven successful in in vivo studies in three Alzheimer s mouse modelsAlzeca has also performed dose ranging studies in mice and pilot PK studies in non human primatesThe goal of this project is therefore to advance ADx MRa liposomal TMR agent to qualify for a pre IND meeting by establishing additional efficacysafetyand scalability data