Bayer 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 to establish ODM-201 efficacy in castration-resistant prostate cancer patients, showing the novel drug provided disease suppression and had a favorable safety profile.
“The field of treatment options for prostate cancer patients is evolving rapidly. However, once prostate cancer becomes resistant to conventional anti-hormonal therapy, many patients will eventually develop metastatic disease. The initiation of a Phase III clinical trial for ODM-201 marks the starting point for a potential new treatment option for patients whose cancer has not yet spread and is an important milestone for Bayer in our ongoing effort to meet the unmet needs of people affected by cancer,” Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development commented in a Bayer press release.
Both Bayer and Orion will develop ODM-201, with Bayer contributing a major share of the costs for future development and commercializing it globally. In turn, Orion will manufacture and co-promote ODM-201 throughout Europe.
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