Jun 4 2007, 7:00 AM EST
News source: Business Wire
Cougar Biotechnology, Inc. (OTCBB: CGRB) today announced that positive interim Phase I and Phase II data on the Company's prostate cancer drug candidate CB7630 (abiraterone acetate) was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, which is currently taking place in Chicago, Illinois. The data was presented in two poster presentations on Saturday, June 2nd, as part of the poster discussion session for genitourinary (prostate) cancer that took place. The poster presentations are further detailed below:
Phase I/II Study of Continuous Oral Dosing of an Irreversible CYP17 Inhibitor, Abiraterone, in Castration-Resistant Prostate Cancer Patients Incorporating the Evaluation of Androgens and Steroid Metabolites in Plasma and Tumor and the Study of Circulating Tumor Cells
The Phase I/II trial of CB7630 was conducted at The Institute of Cancer Research and at The Royal Marsden NHS Foundation Trust in the United Kingdom. In the trial, CB7630 was administered orally, once daily, to chemotherapy-naive patients with castration resistant prostate cancer (CRPC), who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies, including antiandrogens, diethylstilboestrol and dexamethasone. To date, a total of 42 patients have been treated in the Phase I/II trial, including 15 patients treated in the Phase I stage of the trial and 27 patients treated in the Phase II stage of the trial. In his poster presentation, Dr. Gerhardt Attard from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust in the United Kingdom reported that in the 42 patients treated in this trial, 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.
In the 34 patients who were evaluable for response in the Phase I/II trial, 22 patients (65%) experienced a confirmed decline in prostate specific antigen (PSA) levels of greater than 50%, with 10 of the 34 patients (29%) experiencing PSA declines of greater than 90%. Of the 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. Several patients treated with CB7630 also experienced improvement in pain and a notable reduction in opioid use. Circulating tumor cells (CTC) were detected in 16 of 34 patients and changes in CTC counts were shown to correlate with changes in PSA.
Currently 30 of the 42 evaluable patients (71%) in the Phase I/II trial remain on study and continue to be treated with CB7630. Of the 15 patients in the Phase I stage of the trial, 9 patients (60%) are still receiving treatment with CB7630 with the average patient having received the drug for over 9.7 months, including 5 patients having received the drug for over 12 months. Of the 12 patients who started the trial longer than 9 months ago, 8 patients (67%) have shown a confirmed response that has lasted longer than 9 months and these responses continue in all but one of these patients.
In his poster, Dr Attard also provided an update on the Phase II trial of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. 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.
To date, 38 patients have been treated in this Phase II trial with 13 of the patients having been treated for over 3 months. Of t
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