
Curium and PeptiDream completed patient dosing in a Phase 2 trial of 64Cu-PSMA-I&T for prostate cancer in Japan, supporting future regulatory submission.
Curium Group and its partners PeptiDream Inc. and PDRadiopharma Inc. have finished enrolling patients in a registrational Phase 2 trial for the PET imaging agent 64Cu-PSMA-I&T in Japan. The study, which is open-label and single-arm, targets men newly diagnosed with intermediate to very-high-risk prostate cancer who are scheduled for prostatectomy with pelvic lymph node dissection.
The trial evaluates the imaging agent's diagnostic performance and safety. Results will feed into a regulatory submission in Japan, alongside data from Curium's broader global development program.
The same collaborators are also advancing a therapeutic counterpart. In February, Curium announced a registrational trial for 177Lu-PSMA-I&T, a radioligand therapy for metastatic castration-resistant prostate cancer. The two compounds form a theranostic pair – one finds the tumor on a PET scan, the other delivers radiation to it.
"The completion of patient dosing marks an important milestone in the development of 64Cu-PSMA-I&T in Japan," said Patrick C. Reid, president and CEO of PeptiDream. "This program represents a key component of our growing radiopharmaceutical pipeline and our broader theranostics strategy."
Prostate cancer is widely prevalent in Japan. The National Cancer Center Japan reports roughly 90,000 to 100,000 new cases annually.
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