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Orion Oyj Announces Results from Phase I Component of Arades Trial at ESMO 2012 Congress


Sunday, 30 Sep 2012 04:02am EDT 

Orion Oyj announced that Dr. Christophe Massard, Medical Doctor, investigator in ODM-201 ARADES trial presented initial results from the Phase I component of the Arades trial at the ESMO 2012 Congress (European Society for Medical Oncology), in Vienna, September 30 2012. ARADES trial is the first-in-man, open-label, phase I/II safety, pharmacokinetic and proof-of-concept study of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (mCRPC). Based on the Phase I results, the expansion of the ARADES study (Phase II component) started in June 2012 and is ongoing in multiple European countries and in the United States. The ARADES trial is sponsored by Orion Corporation Orion Pharma and Endo Pharmaceuticals, a subsidiary of Endo Health Solutions Inc. (NCT01317641). According to data from the Phase I component, ODM-201 has been well tolerated, with no significant treatment-related adverse events. Prostate specific antigen (PSA) response (defined as >= 50% PSA decrease) was obtained in 13 (87%) of 15 patients currently evaluable at 12-weeks. All six docetaxel-pretreated patients had a PSA decrease at 12-weeks. All evaluable patients so far achieved a partial response or remained stable according, to a set of published rules that define when cancer patients improve, stay the same, or worsen during treatments, at 12-weeks. 

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