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Bayer Phase III ALSYMPCA trial meets primary endpoint

Bayer Healthcare's Phase III, randomized (2:1), double-blind, multi-dose, placebo-controlled ALSYMPCA (ALpharadin in SYMptomatic Prostate Cancer) investigating Alpharadin (radium-223 chloride) has met primary endpoint.

The study evaluated Bayer‘s experimental compound, Alpharadin, licensed from Algeta, in patients who were suffering from castration-resistant prostate cancer (CRPC) and symptomatic bone metastases.

As recommended by an 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 results of the trial demonstrated a statistically prominent overall survival.

Bayer HealthCare Global Development head Kemal Malik said they are encouraged by the overall survival benefit shown in this analysis and are hopeful about the potential of Alpharadin to fill a treatment need for men with advanced prostate cancer.