Positive Phase III Data on Bayer's Investigational Drug Radium-223 Chloride Show Significant Increase in Overal... ( WAYNE N.J. Sept. 23 2011 /- Bayer Hea...)

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Positive Phase III Data on Bayer's Investigational Drug Radium-223 Chloride Show Significant Increase in Overall Survival

Date:9/23/2011

WAYNE, N.J., Sept. 23, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals today announced that the investigational drug radium-223 chloride showed positive data in the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. The study met its primary endpoint by significantly improving overall survival by 44% (p=0.00185, HR=0.695) in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. All of the main secondary efficacy endpoints analyzed to date were met, including delay in skeletal-related events (SREs). These data will be presented during the Presidential Session at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden (Abstract No. 1LBA: Presidential Session I: Best and Late Breaking Abstracts, Saturday, September 24, 13.45 (CEST), Hall A1). The 2011 European Multidisciplinary Cancer Congress is the 16th congress of the European CanCer Organisation (ECCO), the 36th congress of the European Society for Medical Oncology (ESMO) and the 30th congress of the European Society for Therapeutic Radiology and Oncology (ESTRO).

The data showed that patients who were treated with radium-223 chloride had the following outcomes:

Median overall survival of 14 months compared to 11.2 months for the placebo group,
Time to first SREs (13.6 months vs. 8.4 months, 64% improvement, HR=0.610, p=0.00046),
Total alkaline phosphatase (ALP) normalization (33% vs. 1% of patients, p<0.001); and
A 49% improvement in time to prostate-specific antigen (PSA) progression (HR=0.671, p=0.00015).

The most common non-hematologic adverse events (occurring in at least 15% of patients) included bone pain (43% vs. 58%), nausea (34% vs. 32%), diarrhea (22% vs. 13%), constipation (18% vs. 18%) and vomiting (17% vs. 13%); and the most common hematologic adverse events included anemia (27% vs. 27%) for
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