Bayer And Orion Start Phase 3 Trial For Prostate Cancer Drug

Bayer HealthCare, together with its partner Orion Corporation, announced that the companies have begun enrollment of patients in their Phase III trial investigating ODM-201 in male patients with high-risk, non-metastatic, and castration resistant prostate cancer.

ODM-201 is a novel androgen receptor (AR) inhibitor designed to stop the growth of prostate cancer cells. The agent binds to the androgen receptors and blocks receptor function. Results from a Phase II trial show that the drug suppressed prostate cancer and possessed a favorable safety profile.

The double-blind, randomized, multi-center, placebo controlled Phase III trial ARAMIS will investigate the efficacy and safety of oral ODM-201 in men with non-metastatic CRPC with rising Prostate-Specific Antigen (PSA) levels and who are at high risk for developing metastatic disease. ARAMIS will determine ODM-201’s effects on metastasis-free survival (MFS) as its primary endpoint. Secondary objectives include overall survival, time to pain progression, time to first symptomatic skeletal event (SSE), and time to initiation of first cytotoxic chemotherapy, among others. Approximately 1,500 patients will be enrolled in the trial.

Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development at Bayer, said, “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. This is an important milestone for Bayer in our ongoing effort to meet the unmet needs of men affected by prostate cancer.”

Castration-resistant prostate cancer is an advanced form of prostate cancer. The disease is characterized by continuous high-level androgen receptor (AR) function and resistance to standard anti-androgens. Prostate cancer is the fifth leading cause of cancer-related death in men around the world, with an estimated 1.1 million cases being diagnosed in 2012.

Earlier this year, Orion and Bayer announced their agreement to co-develop ODM-201. Orion received an upfront fee of $68 million and raised its outlook for the year as the result of the agreement.