NUCLIDIUM Begins Phase 1 Imaging of ⁶¹Cu Radiotracer for PSMA-positive Prostate Cancer

NUCLIDIUM Announces First Patient Imaged in Phase 1 Study of ⁶¹Cu Radiotracer for Prostate Cancer

NUCLIDIUM has successfully imaged the first patient in its Phase 1 clinical trial evaluating ⁶¹Cu-NuriPro™ (⁶¹Cu-NODAGA-PSMA I&T), a radiotracer designed to safely and accurately diagnose and stage prostate cancer. This candidate is part of NUCLIDIUM’s copper-based NuriPro™ program, targeting Prostate Specific Membrane Antigen (PSMA), a key biomarker in prostate cancer. The company’s diagnostic agent is compared with an FDA-approved ¹⁸F-based PSMA radiotracer.

With a 3.3-hour half-life, ⁶¹Cu-NuriPro™ offers extended distribution time, enabling delayed imaging to detect even the smallest metastases. Its ease of manufacturing at room temperature and simplified workflow reduce the need for specialized equipment, offering key advantages over other radiotracers.

The Phase 1 trial, conducted at Hoag Memorial Hospital Presbyterian in California, will assess safety and diagnostic performance. Early results have shown that ⁶¹Cu-NuriPro™ identified more osseous lesions than its ¹⁸F counterpart. Dr. Gary Ulaner, Principal Investigator, noted the promising potential of the ⁶¹Cu-NuriPro™, which aligns with preclinical findings.

NUCLIDIUM’s CEO, Dr. Leila Jaafar, highlighted the innovation of the company’s copper-based pipeline and its potential to improve prostate cancer staging and treatment. Following this study, NUCLIDIUM plans to advance into a Phase 1/2 trial that will evaluate both the diagnostic and therapeutic applications of its radiopharmaceuticals.

NUCLIDIUM partnered with PharmaLogic Holdings to manufacture and deliver the radiotracers for this trial.

About NUCLIDIUM

NUCLIDIUM is transforming precision oncology with its state-of-the-art copper-based radiopharmaceuticals, delivering unmatched accuracy and accessibility for targeted cancer treatment and diagnosis. Our innovative platform merges copper radiometals with targeted cancer molecules, speeding up the creation of new diagnostic and therapeutic solutions. This portfolio enhances efficacy and safety, offering cost-effective solutions for hospitals and patients. Our unique true theranostic model simplifies development, tackling manufacturing and distribution challenges to increase flexibility for medical providers. Our diverse, interdisciplinary team is dedicated to revolutionizing precision radio-oncology, significantly benefiting cancer patients.

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