ODM-201 is a novel oral androgen receptor (AR) inhibitor for the treatment of advanced prostate cancer, currently preparing for Phase III clinical trials.
Data on ODM-201 from two clinical trials (ARADES and ARAFOR), reviewing safety and efficacy of ODM-201 in chemotherapy and CYP17-inhibitor naïve patients will be presented during the 29th Annual EAU Congress in Stockholm (11-15 April 2014).
The ARADES phase I/II trial (NCT01317641 and NCT01429064) assessed the efficacy and safety of three dose levels of ODM-201 (100mg, 200mg and 700mg given twice a day) in 124 patients.
The ARAFOR trial (NCT01784757) is a bioavailability study also evaluating efficacy and safety for ODM-201 in 30 patients. The current subgroup analysis included chemotherapy and CYP17i-naïve metastatic castration resistant prostate cancer patients from the two trials. It was shown that ODM-201 daily doses between 1200-1800 mg was well tolerated, and produce marked, long-lasting declines in PSA in majority of these patients.
Professor Teuvo Tammela from the University of Tampere, Finland, comments: "ODM-201 is an exciting new therapeutic option for the treatment of prostate cancer. I am really looking forward to its further development into Phase III trials".
View the poster on Orion's website: http://www.orion.fi/en/Research-and-developement/Congress-publications/
Prostate cancer is the most common cancer in the male population in the Western countries. Hormonal deprivation therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with prostate cancer the disease will progress and become castration-resistant. CRPC is characterized by persistent, high level AR function and resistance to conventional anti-androgens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.
ODM-201 is a novel AR inhibitor with unique chemistry that is designed to block the growth of CRPC. ODM-201 binds to AR with high affinity and inhibits receptor function by blocking the nuclear translocation of AR. Unlike other AR inhibitors, ODM-201 does not enter the brain in nonclinical models.
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.
Orion's net sales in 2013 amounted to EUR 1,007 million and the Company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.
Reijo Salonen, Senior Vice President, Research and Development, Orion Corporation tel. +358 50 966 3647
Orionintie 1A, FI-02200 Espoo, Finland