ODM-201 is a novel oral androgen receptor (AR) inhibitor for the treatment of advanced prostate cancer, currently preparing for Phase III clinical trials.
Three posters on ODM-201 from two clinical trials (ARADES and ARAFOR), reviewing pharmacokinetic, safety and efficacy data were presented at the ASCO Genitourinary Cancers Symposium (Jan 30-2 Feb 2014) in San Francisco.
The ARADES phase I/II trial (NCT01317641 and NCT01429064) assessed the efficacy and safety of three dose levels of ODM-201 (100mg, 200mg and 700mg given twice a day) in 124 patients. High PSA response rate in CYP17i-naïve castration resistant prostate cancer (CRPC) patients has been observed in these patients (results presented earlier ESMO12, ASCOGU13, ECCO13). To further analyze the clinical efficacy of ODM-201 in CRPC patients, the response rates on bone and soft tissue were further evaluated. The majority of ODM-201 treated patients had stabilization of disease in soft tissue or avoidance of progression in bone metastases up to 12 weeks.
Of note, ODM-201 has not been observed to enter the brain in pre-clinical models, thus further evaluation of the central nervous system (CNS) safety data was conducted. No ODM-201 patients experienced seizures or related disorders while receiving therapy. These preliminary findings suggest that ODM-201 does not result in a significant CNS safety concern.
The ARAFOR trial (NCT01784757) is a bioavailability study evaluating efficacy and safety for ODM-201, which confirmed similarity between tablet and capsule formulations of ODM-201. Efficacy and safety data up to 12 weeks were presented, which corroborated the efficacy and safety profile seen in the ARADES trial. The safety and efficacy component is still ongoing, with 29 out of 30 patients in the study.
Neal D. Shore, MD, Medical Director, Carolina Urologic Research Center, and an investigator in the ARADES trial, comments: "The development of novel androgen receptor signaling inhibitors(ARSI) is dramatically influencing not only the therapeutic options for CRPC patients but also affecting further clinical trial protocol development in earlier stages of prostate cancer. Improving upon the safety and tolerability as well as the potential efficacy for the ARSI class of agents, portends very well for both clinician and patient adoption for this novel therapeutic (ODM-201)".
View the posters on Orion's website:
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. CRPC is characterized by persistent, high level AR function and resistance to conventional anti-androgens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.
ODM-201 is a novel AR inhibitor with unique chemistry that is designed to block the growth of CRPC. ODM-201 binds to AR with high affinity and inhibits receptor function by blocking the nuclear translocation of AR. Unlike other AR inhibitors, ODM-201 does not enter the brain in nonclinical models.
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.
Reijo Salonen, Senior Vice President, Research and Development, Orion Corporation tel. +358 50 966 3647
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