Status update of the Phase III ARAMIS clinical trial with darolutamide in patients with non-metastatic castration-resistant prostate cancer
Orion announced today that the estimated primary completion date for the joint Phase III clinical trial ARAMIS with darolutamide (NCTNCT02200614) by Orion and Bayer has been updated in the https://clinicaltrials.gov/ -online service. The estimated primary completion date is now updated to September 2018.
About darolutamide (ODM-201; BAY-1841788)
Darolutamide is an investigational novel androgen receptor (AR) inhibitor with specific chemistry that blocks the growth of cancer cells through binding to the AR with a high affinity, and inhibits the receptor function. Unlike some other AR inhibitors, darolutamide has been found to have negligible blood-brain barrier penetration in nonclinical models.
About the ARAMIS trial
The ARAMIS trial is a randomized, Phase III, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of darolutamide in patients with non-metastatic CRPC who are at a high risk for developing metastatic disease.
The primary endpoint of this study is metastasis-free survival (MFS), defined as time between randomization and evidence of metastasis or death from any cause. The secondary objectives of this study are overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, time to pain progression, and characterization of the safety and tolerability of darolutamide.
Senior Vice President, Pharmaceutical Research and Development, Orion Corporation
Tel. +358 50 966 2099
Orionintie 1A, FI-02200 Espoo
Orion is a globally operating Finnish pharmaceutical company - 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. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2017 amounted to EUR 1,085 million and the company had about 3,500 employees. Orion's A and B shares are listed on Nasdaq Helsinki.