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 (PSA) response (defined as >= 50 percent PSA decrease) was obtained in 13 (87 percent) of 15 patients currently evaluable at 12-weeks. All 6 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, M.D., Ph.D., 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 overexpression. Unlike bicalutamide, ODM-201 inhibits AR function by blocking nuclear translocation, and has no agonist activity when AR is overexpressed.
About Prostate Cancer
Prostate cancer is the most common cancer in the male population in the Western countries, second to skin cancer. Hormonal therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with metastatic prostate cancer the disease will progress when it becomes castration-resistant. CRPC is characterized by persistent, high level androgen receptor (AR) function and resistance to conventional antiandrogens such as bicalutamide. Effective treatment options for these patients are still limited, with the field evolving rapidly.
About the Endo/Orion Collaboration
Endo and Orion have a collaboration agreement for the discovery, development and commercialization 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.
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.
Orion's net sales in 2011 amounted to EUR 918 million and the Company had about 3,400 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.
Reijo Salonen, Senior Vice President, Research and Development, Orion Corporation tel. +358 50 966 3647
Orionintie 1A, FI-02200 Espoo, Finland