On April 14, 2014 Orion reported that ODM-201, a novel oral androgen receptor (AR) inhibitor for the treatment of advanced prostate cancer, is 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) (Press release Orion Pharma, APR 14, 2014, View Source [SID:1234500401]).
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.
Download poster presentation (29th Annual EAU Congress Stockholm, Sweden April 11-15, 2014) here, View Source .