This decision follows a successful end-of-Phase II meeting with the FDA, held on January 30, 2009. Algeta began enrolling patients for its global Phase III Alsympca study in June 2008 and aims to enroll approximately 750 hormone-refractory prostate cancer (HRPC) patients with bone metastases. Recruitment of US patients into the study is now planned to commence in 2009.
The Alsympca study is a double-blind, randomized, controlled trial that enrolls symptomatic HRPC patients who will be randomized to receive Alpharadin plus best standard of care or placebo plus best standard of care.
The primary efficacy endpoint of the trial is overall survival. Patients are being randomized two to one in favor of Alpharadin, which will be given as six injections of 50 kBq/kg body weight, four weeks apart.
In addition, the trial will monitor and evaluate both the acute and long-term safety profiles of Alpharadin treatment as well as its impact on quality of life.
Andrew Kay, president and CEO of Algeta, said: Our recent and previous discussions with the FDA have been productive and we believe they have contributed positively to the overall clinical development plan for Alpharadin. We are therefore extremely pleased to enroll US patients into our pivotal Alsympca study following the successful end-of-phase II meeting with the FDA. We will be focusing on initiating the study at key clinical centers in the US over the coming months.