Cougar Biotechnology Announces Initiation of Phase I/II Trial of CB7630 (Abiraterone Acetate) in Advanced Breast Cancer Patients

24-Nov-2008 - United Kingdom

Cougar Biotechnology, Inc. announced that the first patient was enrolled in a Phase I/II clinical trial of the Company's drug candidate CB7630 (abiraterone acetate), an orally active inhibitor of the steroidal enzyme 17alpha-hydroxylase/C17,20 lyase, for the treatment of advanced breast cancer. The Phase I/II trial is being conducted at The Institute of Cancer Research in London and managed by the Drug Development Office of Cancer Research UK, which is funding the trial.

The Phase I/II clinical trial, which is open only to UK women, is an open label, dose escalating study to evaluate the safety and efficacy of CB7630 administered daily to patients with estrogen receptor (ER) positive or androgen receptor (AR) positive, metastatic breast cancer. Patients enrolled in the trial have disease that has progressed after at least two lines of hormonal therapies, such as aromatase inhibitors and tamoxifen.

Dr. Johann S. de Bono, MSc, PhD, MD, FRCP, the principal investigator of the trial from The Institute of Cancer Research, said, "We are pleased to begin enrolling patients in this Phase I/II trial. The mechanism of action of CB7630 may result in the inhibition of many androgenic steroids that may be contributing to disease progression in breast cancer patients. We greatly look forward to continuing enrollment of patients in this Phase I/II trial and further investigating the safety and efficacy of this novel, targeted therapy in breast cancer patients." Dr. Sally Burtles, Cancer Research UK's director of drug development, added, "For women with advanced breast cancer who have stopped responding to the standard treatment available, abiraterone may provide another treatment option."

Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology said, "Initiating the Phase I/II clinical trial of CB7630 in breast cancer patients is an important milestone for the Company and for the clinical development of the drug, as it represents a second potential indication for CB7630."

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