Bayer AG (BAYN.XE) said Friday that it was unblinding early its phase 3 trial of one of its cancer-treatment drugs, following a recommendation from an independent data monitoring committee.
The trial tests the use of radium-223 dichloride, known under the brand name of Xofigo, in combination with abiraterone acetate and prednisone/prednisolone in prostate cancer patients.
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The recommendation came after an observation that the use radium-223 in combination with the two other substances resulted in increased bone fractures and deaths.
"Patient safety is our top priority. We are therefore unblinding the study to thoroughly analyze the data", said Mike Devoy, chief medical officer at Bayer. He added that the company remains committed to further explore the potential of radium-223 across tumor types with unmet medical need.
Radium-223 dichloride has already been approved in more than 50 countries, including the U.S., under the brand name of Xofigo, Bayer said.
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(END) Dow Jones Newswires
December 01, 2017 02:03 ET (07:03 GMT)