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Cougar Biotechnology Announces Presentation of Positive CB7630,Clinical Data at ASCO Annual Meeting

treated, CB7630 was well tolerated with only minimal toxicity in this post-docetaxel population. In the 13 patients who have been in the study for over 3 months, 10 patients (77%) experienced a decline in PSA levels of greater than 50%. Thirty-one of the 38 patients (82%) in this trial are still receiving treatment with CB7630. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use.

Phase I Evaluation of Abiraterone Acetate (CB7630), a 17 Alpha Hydroxylase C17,20-Lyase Inhibitor as Secondary Hormonal Therapy in Castration Resistant Prostate Cancer (CPRC)

The Phase I trial was conducted at the University of California, San Francisco Comprehensive Cancer Center with Charles J. Ryan, MD, Assistant Clinical Professor of Medicine, as the principal investigator. CB7630 was administered once daily to chemotherapy-naive patients with castration refractory prostate cancer (CRPC), who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies.

Of the 25 patients who had been enrolled in the study, 3 patients had "PSA only" disease and 22 patients had either bone or soft tissue metastases. Nineteen of the 25 patients (76%) have received 3 or more cycles of CB7630 and are evaluable for response. Sixteen of 25 patients (64%) had received prior treatment with ketoconazole. Treatment with CB7630 was found to be well tolerated at doses up to 1000 mg/day. In the 25 patients who have been treated with CB7630, 24 of 25 patients (96%) experienced a PSA decline, including 12 of 25 patients (48%) who experienced a greater than 50% decline in PSA and 3 of 25 patients (12%) who experienced a greater than 90% decline in PSA. Prior treatment with ketoconazole was not seen to impact response to abiraterone as 7 of 16 patients (44%) with prior ketoconazole exposure and 3 of 5 patients (60%) with no ketoconazole exposure experienced a greater than 50% decline in PSA. Currently 9 of
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