Bayer And Orion Join Efforts To Test ODM-201In A New Phase 3 Prostate Cancer Trial

Bayer And Orion Join Efforts To Test ODM-201In A New Phase 3 Prostate Cancer Trial
shutterstock_199891940Bayer HealthCare and Orion Corporation recently announced that they have started enrolling patients in a Phase III trial to study ODM-201, an investigational novel oral androgen receptor (AR) inhibitor in clinical development for the treatment of patients with prostate cancer. ARAMIS is a randomized, Phase III, multicenter, double-blind, placebo-controlled trial that will evaluate ODM-201 in men with castration-resistant prostate cancer (CRPC) who have rising Prostate-Specific Antigen (PSA) levels and no detectable metastases. Both companies expect to enroll a total of 1,500 patients, which will be randomized to receive 600mg of ODM-201 twice a day or matching placebo. Primary endpoint for this study is determined as metastasis-free survival and secondary endpoints are set to overall survival, time to first symptomatic skeletal event, time to initiation of first cytotoxic chemotherapy, time to pain progression, and characterization of the safety and tolerability of ODM-201. ODM-201 is an AR inhibitor that upon binding with this receptor, blocks the growth of prostate cancer cells. Importantly, this drug has shown minimal penetration of the blood-brain barrier in laboratory studies. The previous Phase II clinical trial managed
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