On January 19, 2021 ARTMS Inc. (ARTMS) and Isotopia Molecular Imaging (Isotopia) reported that the successful radiolabeling of Isotopia’s prostate cancer imaging kit product, PSMA-11, with over 2 Ci of cyclotron-produced Gallium-68 (68Ga) using ARTMS’ proprietary Quantum Irradiation System (QIS) solid target system (Press release, ARTMS Products, JAN 19, 2021, View Source [SID1234574108]).
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The specially designed Prostate-Specific Membrane Antigen (PSMA) kit for the preparation of 68Ga-PSMA-11 (a radiopharmaceutical targeting PSMA for the imaging of prostate cancer using Positron Emission Tomography (PET)) was radiolabeled with high activity cyclotron produced 68Ga following irradiation times of less than two hours. The Isotopia kit was radiolabeled with between 500 mCi and just over 2900 mCi of 68Ga following multiple successful 68Ga production runs utilizing the QIS and ARTMS’ high performance 68Zn solid targets. The resultant product demonstrated 6-hour stability and radiochemical purity, which met or exceeded all regulatory standards. Cyclotron produced 68Ga combined with a kit solution will give radiopharmacies near unlimited access to this diagnostic product and a cost effective solution.
"The demand for 68Ga radiolabeled products will soon exceed the supply coming from 68Ge/68Ga generators. ARTMS’ QUANTM Irradiation System (QIS) allows for the high activity and high quality 68Ga production the Molecular Imaging community requires to properly serve their patients. The QIS’ multiple-curie per hour 68Ga production is one of the few true game changers I have seen during my career in Nuclear Medicine. We are very excited to bring on-demand 68Ga doses to clinicians and patients in collaboration with our partners," says Charles S. Conroy, Chief Executive Officer of ARTMS.
"Isotopia is focused on developing diagnostic and therapeutic tools that best serve our patients. We see 68Ga as a better diagnostic tool to pair with Lu177 treatments. Isotopia’s high activity PSMA "kit" is a major step forward in how the global imaging community diagnoses prostate cancer. Multi-dose vial preparation will allow pharmacies to provide unit doses and allow clinicians to image patients with little to no restrictions. In addition, a 5 minute preparation and more than 95% radiochemical purity will enhance efficiency and save the radiopharmacies time and money. We aim to keep introducing to the market kit-based solutions for 50 and 100mCi Generators, cyclotron produced 68Ga, and Lu177 labeling," says Dr. Eli Shalom, CEO of Isotopia Molecular Imaging.
ARTMS recently announced the approval for its cyclotron produced 99mTc product by Health Canada. ARTMS will continue the development of cyclotron-based products including 68Ga with a focus on optimizing production potential and satisfying regulatory requirements for use in radiopharmaceutical kits.
About Prostate Cancer
Prostate cancer is the fourth most common cancer worldwide. In 2018, 1.3 million men were diagnosed with prostate cancer for the first time. Despite advances in treatments, prostate cancer still accounts for a significant number of deaths. In 2018, more than 365,000 men died from the disease. Rates of diagnosis are increasing, and the highest levels of prostate cancer are found in the US, Europe, Australia, and New Zealand.