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Ascenta Therapeutics Announces Positive Preliminary Results with AT-101 in Docetaxel Refractory Prostate Cancer
Date:2/27/2009

r Specialists. "Our results to date suggest that stimulating cancer cell apoptosis through Bcl-2 pathways with AT-101 may in fact extend the clinical utility of docetaxel in this cohort of highly treatment-resistant patients."

The analysis included data from 37 men with docetaxel-refractory CRPC who were treated with D (75 mg/m(2) q3 weeks), P (5 mg b.i.d. on days 1-21) and AT-101 (40 mg b.i.d. on days 1-3 of each 21-day cycle). Safety and efficacy were assessed at three-week intervals, with radiological assessments performed at 6-week intervals for patients with soft tissue disease and bone scans performed after cycle 6 and at completion of therapy. Ten of the 37 patients remain on study.

Thirty-eight percent (14/37) of patients treated had at least a 30 percent decrease in PSA level and 19 percent (7/37) achieved a confirmed PR. Twenty patients had measurable disease, five of whom (25 percent) had a PR by RECIST criteria, with additional patients eligible to achieve a response. Four patients have been on therapy for 6 months or more.

Safety data was available for 22 patients. The most common (10 percent or greater) adverse events included fatigue (50 percent), diarrhea (27 percent), nausea, anorexia, and neutropenia (all 23 percent), vomiting and dizziness (18 percent). The most common Grade 3/4 toxicity was neutropenia (23 percent) and was the only Grade 3/4 adverse event that occurred in more than two patients (5 patients). These adverse events were considered manageable and consistent with the safety profile of D/P.

Facts About Prostate Cancer

The American Cancer Society estimates that more than 186,000 new cases of prostate cancer were diagnosed in the United States and that more than 26,000 men died of the disease in 2008, making it the second leading cause of cancer deaths among American men after lung cancer. Approximately half of all patients with prostate cancer su
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SOURCE Ascenta Therapeutics
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