WAYNE, N.J., June 6, 2011 /PRNewswire/ — Bayer HealthCare
Pharmaceuticals Inc. today announced that the Phase III ALSYMPCA
(ALpharadin in SYMptomatic Prostate
CAncer) trial evaluating Bayer’s investigational compound,
radium-223 chloride, which is exclusively licensed from Algeta ASA,
in patients with castration-resistant prostate cancer (CRPC) and
bone metastases met its primary endpoint by significantly improving
overall survival. Based on a recommendation from the
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
radium-223 chloride. 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 radium-223 chloride
and 11.2 months for placebo). The complete results from the
study will be presented at an upcoming scientific meeting.
The safety and tolerability of radium-223 chloride 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
radium-223 chloride. Common adverse events from the ALSYMPCA
trial included diarrhea, neutropenia and thrombocytopenia.
Radium-223 chloride is an investigational agent and is not
approved by the U.S. Food and Drug Administration (FDA), the
European Medicines Agency (EMA) or other health authorities.
“We are pleased that radium-223 chloride met its primary
endpoint of significantly improving overall survival in patients
with CRPC and bone metastases, and are hopeful about the potential
of radium-223 chloride for this patient population,” said Kemal
Malik, MD, Head of Global Development and member of the Bayer
HealthCare Executive Committee.
The company is evaluating the filing strategy for radium-223
chloride based on the IDMC’s recommendation to stop thi