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Bayer's Investigational Compound Radium-223 Chloride Met its Primary Endpoint of Significantly Improving Overall Survival in a Phase III Trial in Patients with Castration-Resistant Prostate Cancer That Has Spread to the Bone
Date:6/5/2011

s study and will offer patients in the placebo arm treatment with radium-223 chloride.

Phase III Trial Design

The ALSYMPCA trial is a Phase III, randomized (2:1), double-blind, multi-dose, placebo-controlled international study of radium-223 chloride plus current standard of care compared with placebo plus current standard of care in patients with symptomatic castration-resistant/hormone-refractory prostate cancer that has spread to the bone.  The primary endpoint of the study is overall survival.  Secondary endpoints include time to occurrence of skeletal related events (SRE), changes and time to progression in prostate-specific antigen (PSA) tests and alkaline phosphatase (ALP) tests, safety and impact on quality of life and health economics.  ALSYMPCA was initiated by Algeta ASA (Oslo, Norway) in June 2008.  Enrollment in the trial was completed in January 2011 and 922 patients were randomized.  

About Radium-223 Chloride

Radium-223 chloride is an investigational pharmaceutical containing an alpha-particle emitting nuclide in development for cancer patients with bone metastases.  In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223 chloride.  Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.  

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in Northern European countries and the United States. In 2008, an estimated 903,000 men had prostate cancer and 250,000 died from the disease worldwide.

Castration-resistant prostate cancer (CRPC) was formerly known as hormone-refractory prostate cancer (HRPC).  Approximately 90 percent of men with CR
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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