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news.Ascenta Therapeutics, a biopharmaceutical company, has announced positive preliminary results from its Phase II study of AT-101 in combination with docetaxel and prednisone in men with docetaxel refractory, castrate resistant prostate cancer.
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Initial findings from the ongoing open-label, multi-center study demonstrates that AT-101 can be administered safely with docetaxel and prednisone (D/P) in these patients. Investigators also observed clinical responses, based on both prostate specific antigen (PSA) and response evaluation criteria in solid tumors (RECIST) criteria, including four patients with a confirmed partial response (PR), defined as a PSA decline of 50% or greater.
The analysis included data from 37 men with docetaxel-refractory castrate resistant prostate cancer who were treated with D (75mg/m(2) q3 weeks), P (5mg bid on days 1-21) and AT-101 (40mg bid on days one to three of each 21-day cycle). Safety and efficacy were assessed at three-week intervals, with radiological assessments performed at six-week intervals for patients with soft tissue disease and bone scans performed after cycle six and at completion of therapy. Approximately 10 of the 37 patients remain on study.
Approximately 38% (14/37) of patients treated had at least a 30% decrease in PSA level and 19% (7/37) achieved a confirmed PR. Approximately 20 patients had measurable disease, five of whom (25%) had a PR by RECIST criteria, with additional patients eligible to achieve a response. Approximately four patients have been on therapy for six months or more. Safety data was available for 22 patients.
AT-101, an oral, pan-Bcl-2 inhibitor currently in double-blinded, randomized Phase II clinical trials in both prostate cancer and non-small cell lung cancer, is the lead compound in Ascenta Therapeutics’s portfolio of apoptosis-triggering small molecules.
Mel Sorensen, CEO of Ascenta, said: “This is the first report of several we plan to present this year from a large and growing data set demonstrating the broad therapeutic potential of AT-101. The evidence of resistance reversal from this refractory population supplements the earlier clinical data demonstrating robust activity with the same regimen in docetaxel-naive patients.”