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Encouraging results from a clinical Phase II trial of ODM-201 for advanced prostate cancer (ARADES Trial)

Prof. Karim Fizazi, M.D., principal investigator in ODM-201 ARADES trial presented today the results from the phase II part of ARADES trial at European Cancer Congress 2013 in Amsterdam. ARADES trial was conducted in patients with progressive metastatic castration-resistant prostate cancer, and it was sponsored by Orion Corporation, Orion Pharma and Endo Pharmaceuticals (NCT01317641). The trial included patients who were treated previously with abiraterone, and/or chemotherapy, or where chemotherapy-naïve.

Encouraging results from a clinical Phase II trial of ODM-201 for advanced prostate cancer (ARADES Trial)

The study assessed the efficacy and safety of three dose levels of ODM-201 (100mg, 200mg and 700mg given twice a day) in 124 patients. The results showed that:

  • ODM-201 had high anticancer activity in all patients.
    • Eighty-six percent of patients who had not received earlier chemotherapy or abiraterone experienced a >50% PSA decrease at week 12 on dose level 700 mg twice a day.
  • ODM-201 was well tolerated in all patients, including patients who had received chemotherapy and abiraterone.
    • Most commonly reported adverse events were Grade 1 or 2, and included fatigue (14%), back pain (14%), and constipation (13%), which were considered to be related to the underlying disease.
    • No related seizures were observed during the trial

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:
"Given its high anticancer activity and its excellent safety profile, ODM-201 is obviously one of the most promising new generation hormonal agents for prostate cancer. I'm now eagerly looking forward to its broader development in various situations of the disease". 

Prostate cancer
Prostate cancer is the most common cancer in the male population in the Western countries. Hormonal deprivation therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with prostate cancer the disease will progress and become castration-resistant. Castrate-resistant prostate cancer is characterized by persistent, high level androgen receptor (AR) function and resistance to conventional antiandrogens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.

About ODM-201
ODM-201 is a novel, new generation, androgen receptor (AR) inhibitor which 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

The poster session
The non-clinical data of  ODM-201 will be presented with a title "ODM-201 - new generation androgen receptor (AR) inhibitor with excellent antiandrogenic and antitumor activity in nonclinical models of CRPC"  in the Poster Session on  "Genitourinary Malignancies - Prostate Cancer" which is scheduled on Monday, 30 September, 2013  from 09:30 to 12:00.

About Orion
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 2012 amounted to EUR 980 million and the Company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.

Contact person:
Reijo Salonen, Senior Vice President, Research and Development, Orion Corporation tel. +358 50 966 3647

Orion Corporation
Orionintie 1A, FI-02200 Espoo, Finland