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Cougar Biotechnology Presents Positive CB7630 Clinical Data at AACR,Annual Meeting Late-Breaking Clinical Trials Session

e 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 11 patients (55%), with 7 patients demonstrating ongoing stable disease and 3 patients experienced regressing bone disease. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use. Circulating tumor cells (CTC) were detected in 14 of 31 patients and changes in CTC counts were shown to correlate with changes in PSA.

Currently 27 (90%) of the 30 patients in the Phase I/II trial remain on study and continue to be treated with CB7630. Of the 15 patients in the Phase I portion of the trial, 12 patients (80%) are still receiving treatment with CB7630, with the average patient having received the drug for over 8.5 months and 4 patients having received the drug for over 12 months.

Abiraterone, an oral, irreversible CYP450c17 enzyme inhibitor appears to have activity in post-docetaxel castration refractory prostate cancer patients

The Phase II trial is being conducted at numerous locations in the United States and United Kingdom. In the trial, CB7630 is administered orally, once daily, to patients with castration refractory prostate cancer who have failed treatment with first line docetaxel based chemotherapy. The oral presentation was made by Dr. Alison H. M. Reid from The Institute of Cancer Research.

To date, 19 patients have been treated in this Phase II trial, with 13 of the patients having been treated for over 3 months. Of the 19 patients who have been treated, CB7630 was well tolerated with only minimal toxicity in this post-docetaxel population. In the 13 patients who have been on study for over 3 months, 8 patients (62%) experienced confirmed declines in PSA levels of greater than 50%, with 2 of the 13 patients (15%) experiencing PSA declines of greater than 90%. All 19 patients in this trial are still receiving treatment with CB7
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