Industry NewsGenitourinary Cancer

Curium Files IND Application for New PSMA Radiopharmaceutical

By News Release


Curium 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, the company 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 US. 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 US. The unique properties of Cu-64 would allow access to PSMA-based prostate cancer imaging in the PET modality to all US 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.”