Bayer to present Phase I and II clinical trial data of Alpharadin in CRPC at 46th ASCO

Bayer HealthCare will present a combined analysis from Phase I and II clinical trials evaluating the safety and efficacy of one of its lead investigational cancer treatments, Alpharadin™ (radium-223 chloride), in castration-resistant prostate cancer (CRPC) that has spread to the bones (metastases).  These data, along with data from a Phase I pharmacokinetic and biodistribution study of Alpharadin, will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4-8, 2010, in Chicago, IL.  

"The analysis of the Phase I and II data presented at ASCO helped to provide the basis for the ongoing global Phase III clinical trial of Alpharadin in CRPC," said Dr. Dimitris Voliotis, Vice President, Oncology Clinical Development, Bayer.  "We are hopeful that the Alpharadin clinical program will aid in addressing treatment for bone metastases in CRPC patients."

Alpharadin Data at ASCO 2010

Abstract #4678 - An analysis of two open-label Phase I trials.

Abstract #4680 - Analysis of data from a Phase I pharmacokinetic and biodistribution study (BC1-08) with escalating doses of Alpharadin in men with bone metastases resulting from CRPC was conducted.  Dose-limiting toxicity (DLT) of Alpharadin was assessed in ten patients during the first four weeks post treatment.  No maximum tolerated dose for Alpharadin was reached in the study, up to 200 kBq/kg.  The analysis also found that Alpharadin clears the blood and accumulates in bone metastases as early as 10 minutes from the time of injection.