Oslo, Norway, 6 June 2011 - Algeta ASA (OSE: ALGETA) today announced that an independent expert committee has recommended stopping its phase III, pivotal, ALSYMPCA study of Alpharadin (radium-223 chloride) for the treatment of bone metastases in patients with castration-resistant prostate cancer (CRPC) on the basis of statistically significant efficacy.
Based on a recommendation from the ALSYMPCA Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study will be stopped and patients on the placebo arm will be offered treatment with Alpharadin. The overall survival result was statistically significant (two-sided p-value = 0.0022, HR = 0.699, the median overall survival was 14.0 months for Alpharadin and 11.2 months for placebo). The complete results from the study will be presented at an upcoming scientific meeting and submitted for publication in a peer-reviewed journal.
The safety and tolerability of Alpharadin were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of Alpharadin.
The ALSYMPCA study (ALpharadin in SYMptomatic Prostate CAncer patients) is an international, double-blind, randomized, placebo-controlled phase III clinical trial evaluating the potential of Alpharadin plus best standard of care versus placebo plus best standard of care to treat symptomatic bone metastases in CRPC patients. The trial began in June 2008, enrollment in the trial was completed in January 2011 and 922 patients were randomized.
Dr Chris Parker, from the Royal Marsden Hospital, and Principal Investigator of ALSYMPCA, said:"Around 90% of men with advanced prostate cancer have bone metastases, which are the main cause of disability and death in this disease. Advanced prostate cancer has a poor prognosis, and treatment options are limited. Based on the observed survival benefit and its safety profile, Alpharadin may become an important treatment for patients with bone metastases from advanced prostate cancer"
Andrew Kay, Algeta's President and CEO, said: "The positive outcome of the ALSYMPCA interim analysis is a tremendous result for Algeta, its shareholders and most importantly for the patients with CRPC who have bone metastases, which is an area of high medical need where there are few treatment options. Alpharadin, potentially the first alpha-pharmaceutical, demonstrated a survival benefit in this trial for patients with bone metastases and this is an exciting time for the company. We would like to thank all the investigators and patients who contributed to this clinical trial."