DEVELOPMENT OF A COPPER 62 PET PERFUSION AGENT

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Positron emission tomography (PET) is a powerful diagnostic imaging technique for non-invasive assessment of regional tissue pathophysiology. Unfortunately, widespread clinical application of PET is currently limited by the high cost and complex regulatory issues associated with production of cyclotron-based positron-emitting radiopharmaceuticals. The principal objective of this project is the commercial development of generator-based copper-62 radiopharmaceuticals that appear promising for clinical use with PET. The 62Cu-n-PrTS and 62Cu-ETS radiopharmaceuticals will continue to be evaluated as tracers for myocardial perfusion; while final testing continues on a modular 62Zn/62Cu generator system configured for on- line radiopharmaceutical synthesis and delivery. For the agent that performs best in pre-clinical studies, data and supporting documentation will be assembled for creation of a Drug Master File and a Notice of Claimed Investigational Exemption for a New Drug (IND). Phase I and Phase II clinical trials with the selected 62Cu- radiopharmaceutical will begin in Year 2 of the project. Concurrent synthetic research will be directed towards broadening the spectrum of 62Cu-agents that can be delivered for clinical use. Successful commercial development of these 62Cu-radiopharmaceuticals would facilitate economical application of PET technology in the diagnostic evaluation of patients with coronary artery disease. PROPOSED COMMERCIAL APPLICATION: This project seeks to develop promising new 62Cu-radiopharmaceuticals for use in conjunction with the Proportional Technologies modular 62Zn/62Cu generator system. The integrated 62Cu-generator and radiopharmaceutical delivery system is suitable for nationwide delivery and is expected to substantially reduce the cost associated with diagnostic use of positron emission tomography (PET) in evaluation of tissue perfusion.