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Promising preclinical and Phase I data of a new generation androgen receptor (AR) inhibitor, ODM- 201, presented at ASCO GU 2013 symposium

Press release 15 February 2013 at 9.00 am EET

Promising preclinical and Phase I data of a new generation androgen receptor (AR) inhibitor, ODM- 201, presented at ASCO GU 2013 symposium

Prof Karim Fizazi, M.D., principal investigator in ODM-201 ARADES trial presented results from preclinical experiments and the Phase I component of the Arades trial at the 2013 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO) in Orlando, FL on Thursday 14 February 2013.

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.

Orion Corporation and Endo Pharmaceuticals Inc. are jointly developing an androgen receptor inhibitor (ODM-201) for the treatment of advanced prostate cancer with the objective of approval of the drug globally. Preclinical and Phase I clinical trials on safety, efficacy and pharmacokinetics showed that initial results concerning efficacy were promising, and the product was well tolerated with no significant adverse events detected. The results were presented at the ESMO international oncology congress at the end of September 2012. Development of the product is now in Phase II clinical trials.

In preclinical experiments, ODM-201 was shown to bind to wild type AR with superior affinity compared to enzalutamide. In the VCaP CRPC model, ODM-201 significantly inhibited tumor growth compared to castrated control (p<0.001) and enzalutamide (p<0.05).  After oral administration, tissue/plasma ratio of ODM-201 in mouse brain homogenates was negligible in all studied doses.  The 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) 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 17 (81%) of 21 patients evaluable during 12 weeks. Moreover, a >50% PSA decrease from baseline in abiraterone-naïve patients was seen in 92% of pre-chemo and 86% of post-chemo patients.  For post-abiraterone, post-chemo patients this decrease was seen in 67% of patients.

About ODM-201

ODM-201 is a novel, new generation, androgen receptor (AR) inhibitor 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 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.  Orion will have marketing rights in Europe, including Russia, while Endo will retain marketing rights for North America.

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, Communications, Orionintie 1A, FI-02200 Espoo, Finland