ST. LOUIS, MO, USA I October 27, 2021 I Curium announced today that the Company has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin its Phase 3 trial with its investigational product lutetium Lu 177 PSMA I&T, a therapeutic radiopharmaceutical that binds to the Prostate-Specific Membrane Antigen (PSMA) protein. Curium is working closely with sites across the U.S. to initiate the ECLIPSE trial (A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer).

If approved, Curium expects to manufacture the product in its Noblesville, Indiana facility, leveraging its centralized production capabilities and logistical expertise. “We are excited about advancing Lu 177 PSMA I&T to the clinical trial stage, particularly in light of our recent announcement for our Cu 64 PSMA I&T imaging agent.  We believe this represents an exciting opportunity for patients nationwide and their healthcare providers,” said Curium CEO, North America, Mike Patterson.

“We are committed to working closely with the FDA to potentially bring this new therapeutic radiopharmaceutical agent to patients and their healthcare professionals,” 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.” 

About Curium

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. 

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SOURCE: Curium