PROPORTIONAL TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase I: NCI

Description

Project Summary This Phase research project will develop a somatostatin receptor targeted Cu radiopharmaceutical for clinical imaging of neuroendocrine tumors with positron emission tomography PET The short lived Cu radiolabel is readily and repeatedly available for on demand radiopharmaceutical labeling via a compact modular Zn Cu radionuclide generator system developed by Proportional Technologies Inc Somatostatin receptors are found to be highly expressed by most neuroendocrine tumors and are a well established molecular target for PET detection of these malignancies with a family of Ga labeled receptor targeted peptides that have come into widespread clinical use outside the USA This project will develop an alternative approach to PET imaging of neuroendocrine tumors employing Cu DOTA TATE as a radiopharmaceutical that can readily be employed for assessment of tumor burden while still allowing immediate independent F FDG PET assessment of tumor aggressiveness thus more fully characterizing the individualandapos s disease state Cu DOTA TATE will also be attractive for neuroendocrine tumor imaging in pediatrics due to relatively low patient radiation exposure when imaging with such a short lived nuclide Our commercialization approach will be to seek FDA approval for the combination of our Cu generator and a companion sterile kit that allows on demand technologist compounding of the Cu DOTA TATE radiopharmaceutical immediately prior to injection For this Phase project our Specific Aims are to produce and validate a lyophilized kit formulation for on demand clinical site compounding of Cu DOTA TATE and to evaluate Cu DOTA TATE distribution pharmacokinetics and dosimetry in humans Additionally the feasibility of whole body Cu DOTA TATE tumor imaging will be documented by direct comparison of Cu findings to contemporaneous clinical exams obtained with In OctreoScan SPECT or Ga DOTA NOC PET These Phase experiments are expected to demonstrate that Cu DOTA TATE can be reliably and robustly compounded at high radiochemical purity and that whole body Cu DOTA TATE PET appears suitable for clinical neuroendocrine tumor imaging thereby establishing the foundation for Phase studies to assess the efficacy of Cu DOTA TATE PET CT in patient management Statement of Relevance This project will advance public health by development of an imaging technology that improves detection of neuroendocrine tumors as well as physicianandapos s ability to plan appropriate treatment of patients with neuroendocrine cancer The proposed tumor targeted copper radiopharmaceutical can be commercially distributed to any clinical PET imaging facility in the United States relying on a longer lived zinc copper parent daughter radionuclide generator system already developed by Proportional Technologies Inc thereby providing universal patient access to receptor based PET neuroendocrine tumor imaging