Saint-Genis-Pouilly, France, June 22, 2018 – Advanced Accelerator Applications S.A. (AAA), a Novartis company and leader in nuclear medicine theragnostics, today announced that the first patients have been dosed in two Phase I/II clinical studies of radiolabeled PSMA-R2, a urea-based ligand of Prostate-Specific Membrane Antigen (PSMA), which is commonly expressed on prostate cancer cells.
The PROter study is an open-label, multi-center, dose-escalation/dose-expansion trial evaluating treatment with 177Lu-PSMA-R2 RadioLigand Therapy in patients with PSMA positive progressive, metastatic castration-resistant prostate cancer following previous systemic treatment. Primary objectives for Phase I include characterizing the drug’s safety profile and tolerability, as well identifying a recommended Phase II dose. The primary objective for Phase II is assessment of antitumor activity, as measured by radiographic progression-free survival. Other objectives include prostate-specific antigen (PSA) response, time to PSA progression and overall survival. Approximately 96 patients are expected to be enrolled in the PROter trial.
The PROfind study is an open-label, multi-center trial evaluating Positron Emission Tomography (PET) imaging with 68Ga-PSMA-R2 in patients with biochemical relapse and metastatic prostate cancer. The primary objective of the study is to assess the safety and tolerability of a single administration of 68Ga-PSMA-R2. Secondary objectives include evaluation of pharmacokinetics, biodistribution and
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