NUCLIDIUM today announced the successful imaging of the first patient in a Phase 1 clinical trial evaluating its radiotracer candidate as a safe and effective diagnostic and disease-staging tool in prostate cancer patients. The candidate, 61Cu-NuriPro™ (61Cu-NODAGA-PSMA I&T), is part of NUCLIDIUM’s NuriPro™ program, which targets Prostate Specific Membrane Antigen (PSMA), a well-established biomarker in the diagnosis, staging, and treatment of certain types of prostate cancer. This is the first candidate from NUCLIDIUM’s copper-based radiopharmaceutical pipeline to enter clinical trials, with its therapeutic counterpart, 67Cu-NuriPro™ (67Cu-NODAGA-PSMA I&T), currently in preclinical development and expected to begin a Phase 1 trial in 2025.
The non-randomized, investigator-initiated Phase 1 trial is being conducted at Hoag Memorial Hospital Presbyterian in Newport Beach, California. It aims to assess the safety and diagnostic accuracy of 61Cu-NuriPro™ in prostate cancer imaging, compared to an FDA-approved PSMA-targeting radiotracer based on 18F. The 61Cu-based radiotracer offers potential advantages over existing agents, including a longer half-life of 3.3 hours, which allows for greater distribution and the possibility of delayed imaging to detect smaller metastases. Additionally, 61Cu-NuriPro™ can be easily produced at room temperature, simplifying workflow and reducing the need for complex laboratory equipment.
NUCLIDIUM has partnered with PharmaLogic Holdings, who manufactures the diagnostic tracers at their Los Angeles facility and delivers them to Hoag Memorial Hospital in a ready-to-inject form. This collaboration, established in 2023, leverages NUCLIDIUM’s proprietary technology and PharmaLogic’s production expertise to ensure high-quality radiopharmaceuticals.
Dr. Gary Ulaner, MD, PhD, Director of Molecular Imaging and Therapy at Hoag Memorial Hospital Presbyterian and the trial’s Principal Investigator, commented on the significance of the study: “Prostate cancer is the most commonly diagnosed cancer in American men and the second leading cause of cancer death. Rapid and accurate diagnosis is key to effective treatment. Our study aims to evaluate the safety of 61Cu-NuriPro™ and compare its diagnostic performance to an FDA-approved radiotracer. So far, the first patient has experienced no adverse events, and the scan at 1 hour post-injection revealed more osseous lesions than the 18F-based radiotracer. Additionally, PET scans at 2 and 4 hours post-injection detected even more lesions, highlighting the imaging potential of 61Cu-NuriPro™.”
Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM, added: “This trial marks a critical milestone in building the clinical evidence for our copper-based radiopharmaceuticals, which have shown superior imaging capabilities with lower toxicity in preclinical studies. Copper’s unique properties enable us to establish a true theranostic pipeline that offers more precise disease staging and treatment for individual patients. Our NuriPro™ diagnostic has the potential to address significant challenges in both detection and production, and we look forward to exploring its impact on the treatment of prostate cancer.
