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Cougar Biotechnology Announces Presentation of Positive CB7630,Clinical Data at ESMO Conference

th LHRH analogs and antiandrogens, 21 patients (70%) had failed treatment with steroids and 15 patients (50%) had failed treatment with diethylstilboestrol. Moreover, all of the patients in the study had failed treatment with docetaxel and 10 patients (33%) had failed treatment with an additional cytotoxic agent (mitoxantrone, estramustine, vinorelbine, cyclophosphamide).

Of the 30 patients who have been treated, CB7630 was well tolerated with only minimal toxicity in this post-docetaxel population. In the 21 patients who have been in the study for over 3 months, 10 patients (48%) experienced a confirmed decline in PSA levels of greater than 50% and 2 patients (10%) experienced PSA declines of greater than 90%. Of the 12 evaluable patients with measurable tumor lesions, 2 patients (17%) experienced confirmed partial radiological responses (as measured by the RECIST criteria), 1 patient (8%) experienced an unconfirmed partial response and 5 patients experienced ongoing stable disease (including one patient with a minor response). Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use. Twenty-eight of the 43 patients (65%) enrolled in this trial are still receiving treatment with CB7630.

Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "The data on CB7630 presented at the ESMO Conference is important for several reasons. First, not only does it confirm the earlier signal of clinical activity in second line hormonal therapy patients, but it also for the first time demonstrates that CB7630 is capable of impacting time to progression in patients with metastatic disease. The time to progression data presented in the CB7630 trial compares favorably to that which has been reported for other currently used second line hormonal therapies. Second, the data provides additional confirmation of CB7630's activity in second line chemotherapy patients. As both
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