BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Ortho Biotech Oncology Research & Development Release: Study of Investigational Agent Abiraterone Acetate for Metastatic Advanced Prostate Cancer Unblinded After Meeting Pre-Determined Criteria


9/10/2010 12:55:14 PM

LOS ANGELES, CA, September 9, 2010 – 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 US in October and in sites outside the US 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.)

For further information contact:

BTG Financial Dynamics Andy Burrows, Director of Investor Relations +44 (0)7990 530605 Rolf Soderstrom, Chief Financial Officer +44 (0)20 7575 0000 Ben Atwell +44 (0)20 7831 3113

About BTG

BTG is an international specialty pharmaceuticals company that is developing and commercialising products targeting critical care, cancer, neurological and other disorders. The company is also seeking to acquire new products to develop and market to hospital specialists, and is building a sustainable business financed by revenues from sales of its critical care products and from royalties and milestone payments on partnered products. For further information, visit: www.btgplc.com.

Juliet Edwards Assistant Financial Communications

Holborn Gate, 26 Southampton Buildings London, WC2A 1PB T +44 (0)20 7269 7125 F +44 (0)20 7242 8695

www.fd.com



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->