Dr Christophe Massard, MD, 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, 30th September 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, expansion of the ARADES study (Phase II component) started in June 2012 and is ongoing in multiple European countries and in the US. 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 (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.
Principal investigator of ARADES trial, Prof. Karim Fizazi, MD, PhD, Head of the Department of Cancer Medicine at Institut Gustave Roussy, Villejuif, France, comments that ODM-201 showed good tolerability and anti-cancer activity in patients with mCRPC, including docetaxel-pretreated patients, in this Phase I trial. “It is really rare in my experience to see a drug so benefiting in such an early phase of development to most patients, and I’m excited that we can now pursue the assessment of ODM-201 in more patients with mCRPC, including hard-to-treat disease situations” he says.
ODM-201 is a novel, new generation, androgen receptor (AR) antagonist that does not, unlike other anti-androgens, enter the brain in nonclinical models, and lacks the partial agonist activity seen with bicalutamide in the setting of AR over-expression. Unlike bicalutamide, ODM-201 inhibits AR function by blocking nuclear translocation, and has no agonist activity when AR is over-expressed.