Oslo, Norway, 5 January - Algeta ASA (OSE: ALGETA) has completed enrolment of the targeted 900 patients into its ALSYMPCA phase III clinical trial with Alpharadin (radium-223 chloride).
The ALSYMPCA study (ALpharadin in SYMptomatic Prostate CAncer patients) is a double-blind randomized, placebo-controlled phase III clinical trial evaluating the potential of Alpharadin to treat castration-resistant prostate cancer (CRPC) patients with bone metastases. Bone metastases are the main cause of disability and death in patients with CRPC and approximately 90% of men with this disease have radiological evidence of bone metastasis.
The primary efficacy endpoint of ALSYMPCA is overall survival. The trial also evaluates both the safety profile of Alpharadin treatment and its impact on quality of life.
The trial began in June 2008 and is being conducted at more than 140 clinical centers worldwide, including 14 centers in the United States. Results of the trial are anticipated in 2012 and could allow a regulatory filing in 2012.
Alpharadin (radium-223 chloride) is being developed by Algeta and Bayer Schering Pharma AG. It is a first-in-class alpha-pharmaceutical that in Phase II trials showed a statistically significant improvement in overall survival compared to placebo (approximately 40% improvement, p=0.017, hazard ratio 0.48), a consistent improvement in disease-related biomarkers and pain, and a favorable side-effect profile.
Andrew Kay, Algeta's President and CEO, said: "Reaching the planned 900-patient target for ALSYMPCA on schedule is a major achievement for Algeta and allows us to stay on track for reporting top-line results in 2012. I would like to recognise the sustained efforts of the clinical and development teams, the investigators and partners in keeping the trial on schedule and getting us to this position."