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 27 patients who were enrolled in the study, 18 patients were administered CB7630 on an empty stomach while nine patients received CB7630 on a full stomach (with a high fat calorie meal). Treatment with CB7630 was found to be well tolerated in both the fasted and fed groups. The safety profile of the drug was seen to be unaffected by administration of the drug with food.
In the 27 patients who were treated with CB7630 in both the fasted and fed groups, 16 of 27 patients (59%) experienced a greater than 50% decline in prostate specific antigen (PSA) levels. Furthermore, 11 of the 18 patients (61%) in the fasted group and five of the nine patients (56%) in the fed group experienced a greater than 50% decline in PSA levels.
Alan Auerbach, CEO and president of Cougar Biotechnology, said: “We greatly look forward to the continued development of CB7630 in both the second line hormone therapy and second line chemotherapy settings.”