Study of Investigational Agent Abiraterone Acetate for Metastatic Advanced Prostate Cancer Unblinded After Meeting Pre-Determined Criteria
LOS ANGELES, Sept. 9 /PRNewswire/ -- Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., today announced that it has unblinded the Phase 3 study of abiraterone acetate plus prednisone for the treatment of patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer) whose disease has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.
Study COU-AA-301 included 1,195 patients who were randomized to receive abiraterone acetate plus prednisone or placebo plus prednisone.
The Independent Data Monitoring Committee's (IDMC) recommendation to unblind the study was based on a pre-specified interim analysis, which demonstrated a statistically significant improvement in overall survival and an acceptable safety profile. Based on these results, the IDMC also recommended that patients in the placebo arm be offered treatment with abiraterone acetate.
A program that will provide early access to abiraterone acetate to patients who meet specified medical criteria is being initiated. Participating centers will be listed on www.clinicaltrials.gov when they are ready to enroll patients. The company anticipates opening the program in the United States in October and in sites outside the United States in the months following, contingent on local health authority and ethics committee approvals.
These results will be presented at the upcoming European Society for Medical Oncology congress, which is held in Milan, October 8-12, 2010. They will also be submitted for publication in a peer-reviewed journal.
Abiraterone acetate is an investigational drug; its safety and efficacy have not yet been established. The company is evaluating the filing strategy for abiraterone acetate, based on the IDMC's recommendation to unblind this study.
About the Ortho Biotech Oncology Research & Development Unit of Cougar Biotechnology, Inc.
As an affiliate of Johnson & Johnson Pharmaceutical Research & Development, Inc., Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., is a research and development organization dedicated to oncology and supportive care. It partners closely with Centocor Ortho Biotech Inc. and Janssen-Cilag companies worldwide to bring oncology treatments and supportive medicines to patients around the world.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
SOURCE Ortho Biotech Oncology Research & Development
Posted: September 2010