Date: 2014-04-14
Type of information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the 29th Annual EAU Congress in Stockholm
Company: Orion Corporation (Finland)
Product: ODM-201
Action
mechanism: ODM-201 is a novel oral androgen receptor (AR) inhibitor for the treatment of advanced prostate cancer, currently preparing for Phase III clinical trials.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: 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.
Latest
news: * On April 14, 2014, Orion Corporation has announced the presentation of 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 (poster 11-15 April 2014). ARADES phase I/II trial 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 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. Forty-one mCRPC patients were included in the analysis. OMD-201 daily doses between 1200-1800 mg is well tolerated and produce marked, long-lasting declines in PSA in majority of mCRPC patients who are naïve for chemotherapy and CYP1-inhibitor treatment. At 4 and 12 weeks, ?50% PSA decreases from baseline were observed in 82% (32/39) and 85% (33/39) of patients respectively. The corresponding >90% PSA response rates were 10% (4/39) and 31% (12/39) respectively.
