Novel AR drug hope for prostate cancer
Bayer HealthCare and Orion Corporation are enrolling prostate cancer patients in a phase III trial with ODM-201, an investigational oral androgen receptor (AR) inhibitor.
The study, ARAMIS, is set to evaluate ODM-201 in men with castration-resistant prostate cancer who have rising Prostate Specific Antigen (PSA) levels and no detectable metastases. It is designed to determine the effects of the treatment on metastasis-free survival (MFS).
“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,” explained Dr Joerg Moeller of the Bayer HealthCare executive committee and head of global development. “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.”
Earlier this year, Bayer and Orion entered into a global agreement to jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. As part of the deal Orion received an upfront payment of EUR 50 million, much of which will fund the costs of the phase III study.
Bayer will commercialise ODM-201 globally, and Orion has the option to co-promote it in Europe. Orion will be responsible for manufacture.
ODM-201 is thought to block the growth of prostate cancer cells. It binds to the AR and inhibits receptor function by blocking its cellular function. Unlike other AR inhibitors, ODM-201 does not enter the brain in nonclinical models.
Bayer has three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritises targets and pathways with the potential to impact the way that cancer is treated.
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