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Further Information
Prostate cancer is the most common non-skin cancer in the US, affecting one in six men. Genetic, social and environmental factors such as diet and lifestyle are believed to be involved in its development. Treatments include surgery, radiotherapy, hormone therapy and chemotherapy. Over 90% of cancers that are diagnosed and treated early are cured.

The hormone testosterone stimulates the growth of prostate cancer cells. By selectively inhibiting the steroidal enzyme 17α-hydroxylase/C17,20 lyase, a cytochrome p450 complex that is involved in testosterone production, CB7630 inhibits testosterone production in both the adrenals and the testes.

CB7630 entered Phase III trials in April 2008. The Phase III trial is a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based chemotherapy. Similar to the patient populations in Cougar’s Phase II trials COU-AA-003 and COU-AA-004, patients are allowed to have received up to two prior chemotherapy regimens before entering the trial. The trial will enroll approximately 1,160 patients who will be randomized (2:1) to receive either CB7630 plus prednisone or placebo plus prednisone. The trial will be conducted at approximately 150 sites in North America, Europe and Australia. The primary endpoint of the trial will be overall survival.

Cougar will initiate a Phase I/II trial of CB7630 in advanced breast cancer by mid-2008 and plans to present interim data from this trial in late 2008.

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