Dr Christophe Massard, investigator in the ODM-201 ARADES trial, has presented initial results from the Phase I component of the ARADES trial at the ESMO 2012 Congress (European Society for Medical Oncology), in Vienna, Austria. The ARADES trial is a 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 and Endo Pharmaceuticals, a subsidiary of Endo Health Solutions.
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 per cent PSA decrease) was obtained in 13 (87 per cent) of 15 patients currently evaluable at 12 weeks. All six docetaxel-pre-treated 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.
ODM-201 is a new-generation, androgen receptor (AR) antagonist that does not, unlike other anti-androgens, enter the brain in non-clinical 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.
Endo and Orion have a collaboration agreement for the discovery, development and commercialisation of assets in oncology. The companies co-develop the assets coming out of this collaboration and share all development costs. Orion will have marketing rights in Europe, including Russia, while Endo will retain marketing rights for North America.