24th August 2021
Curium Announces Submission of an Investigational New Drug (IND) Application for Cu-64 PSMA I&T
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(ST. LOUIS, MO – August 24, 2021) – Curium announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Cu-64 PSMA I&T, a radiopharmaceutical that binds to Prostate-Specific Membrane Antigen (PSMA) for use with Positron Emission Tomography (PET), for the detection and localization of metastatic prostate cancer. If approved, Curium expects that its Cu-64 PSMA I&T would be the first Cu-64 PSMA I&T agent for imaging of prostate cancer available in the U.S. With the benefit of Cu-64’s 12.7-hour half-life, Curium has the ability to manufacture Cu-64 products centrally at its Maryland Heights, Missouri facility and distribute throughout the U.S. The unique properties of Cu-64 would allow access to PSMA-based prostate cancer imaging in the PET modality to all U.S. imaging sites without local cyclotron production or access to a nearby gallium generator.
“We are excited about advancing Cu-64 PSMA to the clinical trial stage and advancing Curium’s copper-based radiopharmaceutical imaging platform. The imaging market has broadly adopted our recently approved Cu-64 imaging agent,” said Curium Interim CEO, North America, Mike Patterson. “If approved, a Cu-64 PSMA imaging agent would bring unique attributes to the prostate cancer imaging market, including easy access to the product, convenience, and flexibility.”
“We are committed to working closely with the FDA to potentially bring a new radiopharmaceutical imaging agent to patients and their healthcare professionals in the imaging of prostate cancer using PET,” said Curium Vice President of Medical and Compliance, Ed Porter. “We look forward to engaging additional clinical trial sites as we finalize our clinical development program.”
Curium is the world’s largest nuclear medicine company. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for potentially life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine.