Curium announces achievement of co-primary endpoints in phase 2 of its phase 1/2 SOLAR clinical trial imaging men with histologically-proven prostate cancer using copper Cu 64 PSMA I&T

(Paris, France – 15 August 2023) Curium, a world leader in nuclear medicine, announced today the positive results of the multi-center, open-label, Phase 2 SOLAR study of Copper Cu 64 PSMA I&T in patients with histologically-proven metastatic prostate cancer. The study has met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate.  The purpose of this study was to evaluate the safety, biodistribution, and image quality of Copper Cu 64 PSMA I&T to detect metastatic prostate cancer using PET/CT imaging. The SOLAR Phase 2 study was conducted in the U.S. and included a group of 26 patients with metastatic prostate cancer.

Michael Patterson, CEO – North America at Curium commented, “The milestone announced today demonstrates Curium’s global commitment to driving innovations in prostate cancer diagnosis and treatment, and is extremely encouraging for prostate cancer patients.  Our proven ability to reliably manufacture and distribute Cu-64 diagnostic agents throughout the U.S. means that we are well positioned for the upcoming Phase 3 trials to ultimately improve the lives of patients.”

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “We are very pleased to report that our Copper Cu 64 PSMA I&T product for PET/CT imaging in the detection of recurrent prostate cancer has met the co-primary endpoints.  Consistent with our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are encouraged by the readouts of the SOLAR Phase 2 clinical trial. Our goal is to accelerate the Copper Cu 64 PSMA I&T Phase 3 clinical development and move forward with pivotal Phase 3 clinical trials in biochemical recurrence and initial staging setting in metastatic prostate cancer in early 2024.”

Prostate cancer is the second most common cancer after skin cancer among men in the United States.  There will be an estimated 288,000 new cases of prostate cancer in 2023.

For more information about the SOLAR trial: https://www.curiumpharma.com/resources/current-clinical-trials/solar-clinical-trial/

To contact Curium’s SOLAR clinical trial team: solar@curiumpharma.com