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National Cancer Research Institute Cancer Conference

Cougar Biotechnology, Inc., a publicly held biotechnology company, announced positive Phase I data on the Company's prostate cancer drug CB7630 (abiraterone acetate). The data was presented during the plenary session at the National Cancer Research Institute (NCRI) Cancer Conference that is currently taking place October 8-11, 2006 in Birmingham, UK.

In the trial, CB7630 was administered once daily to chemotherapy-naïve patients with CRPC, who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies including antiandrogens, diethylstilboestrol and dexamethasone. The results from the trial presented at the conference showed that in the 14 patients tested, CB7630 was well tolerated at doses as high as 2000 mg/day with minimal toxicity. Moreover, no dose limiting toxicity has been observed in the trial to date. Of the 12 patients that were evaluable for antitumor activity, 8 patients (67%) experienced a confirmed decline in prostate specific antigen (PSA) levels of greater than 50% and 6 patients (50%) experienced PSA declines of greater than 90%. Of the 5 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 3 (60%) patients. Individual patients treated with CB7630 also experienced radiographic regression of bone metastases and improvement in pain. Circulating tumor cells (CTC) were detected in 6 of 14 patients and changes in CTC counts were shown to correlate with changes in PSA. 10 (71%) of the 14 patients continue on treatment with CB7630, with some patients having been on the drug for over 9 months.



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