Development of Tumor Proliferation PET Tracer FLT using a Low Cost Single Dose Automatic Production and Quality Control Biomarker Generator System

DESCRIPTION provided by applicant Worldwide a person dies from cancer every seconds Positron emission tomography PET is an effective tool that is critical in diagnosing cancer and monitoring treatment efficacy PET imaging relies on use of short lived radioisotopes Commercial distribution of the most commonly used radio tracer F FDG has resulted in patient population coverage in the U S Western Europe and Japan However the andquot emerging worldandquot of the worldandapos s population still does not have ready access to F FDG ABT Molecular Imaging Inc ABT is focused on increasing PET access in the U S and worldwide The firmandapos s proprietary andquot Dose on Demand tm andquot Biomarker Generator BG greatly simplifies production of F FDG It also reduces the investment required by healthcare institutions to introduce PET diagnostics into new regions The need for PET related advances remains however The F FDG biomarker is not the only one required for successful diagnosis treatment monitoring of cancers F FLT has been shown to provide complementary information F FDG regarding tumor proliferation in a range of cancers constituting of all existing cases see Comm Plan Section A yet it costs $ $ dose where available F FLT has shown so much promise that the National Cancer Institute has an established IND for F FLT to actively encourage investigators to cross file on there are more than clinical trials The Fast Track SBIR project proposed here will provide the funding needed to develop and validate ABTandapos s ability to automatically synthesize and perform automatic QC testing on F FLT simplifying site IND submissions with ABT support The envisioned ABT system will generate F FLT for $ dose using disposable dose synthesis cards that can be used in between F FDG doses The challenges to integrating F FLT are producing enough F to account for the synthesis yield of F FLT automating synthesis and automating QC tests of F FLT on the BG system For this Fast Track ABTandapos s PI Dr Khachaturian will lead an expert Randamp D team of in pursuing Phase I and Phase II Aims Aim Validate the feasibility of increasing the amount of F produced by the cyclotron from to mCi min Aim produce one unit dose of F FLT mL mCi with both US and EU precursors and Aim pass the US and EU pharmacopeia quality controls tests Phase I verification will fully validate proof of concept such that Phase II development ca focus on ensuring consistent F FLT yield and quality for manufacturing The Phase II Aims are Aim F yield shall be andgt mCi min at s for n targets and runs target Aim consecutive unit doses of F FLT can be synthesized with both labeling precursors and Aim consecutive unit F FLT doses will pass the US and EU pharmacopeia requirements Phase III support will come from ABTandapos s current investors and will enable the distribution of F FLT contingent upon receiving the NIH Fast Track support and meeting the Phase I and II Randamp D goals PUBLIC HEALTH RELEVANCE Even with the great recent advances we have made against cancer a person still dies from the disease every seconds meaning that we still have much more yet to do in terms of diagnosing monitoring and treating cancer Positron Emission Tomography PET is an effective tool that is critical in diagnosing cancer and monitoring treatment and F FLT is an important PET biomarker than can be used to image tumor proliferation yet F FLT availability is limited in the U S and worldwide by high costs $ $ dose This Fast Track SBIR project is focused on developing and commercializing a novel method of producing F FLT that would reduce the cost to $ dose via proprietary ABT technology thereby making this enabling component of PET based cancer monitoring much more available throughout the U S and internationally