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Re: pcrutch post# 171672

Wednesday, 04/02/2014 2:07:57 PM

Wednesday, April 02, 2014 2:07:57 PM

Post# of 257472
Bayer starts phase-3 trial testing Zytiga ± Xofigo in first-line mCRPC:

http://finance.yahoo.com/news/bayer-initiates-phase-3-trial-063000554.html

Bayer HealthCare Pharmaceuticals Inc. today announced that the company has begun to enroll patients in a trial studying Xofigo…in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naive patients with bone predominant metastatic castration-resistant prostate cancer (mCRPC). The randomized, double-blind, placebo-controlled Phase 3 trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival [i.e. that’s the primary endpoint].

The trial is expected to enroll 800 patients with primary-endpoint results in Jul 2017 (http://www.clinicaltrials.gov/ct2/show/NCT02043678 ). JNJ is cooperating with Bayer, which presumably means that Bayer doesn’t have to pay for the Zytiga used in the trial.

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