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news.Novacea has initiated a pivotal phase III clinical study evaluating the combination of the company's novel oral anticancer agent, DN-101, and Taxotere in men with prostate cancer for whom hormonal therapy is no longer working.
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This randomized, controlled, multi-national study is seeking to enroll approximately 900 patients at over 125 medical centers in the US, Europe, and Canada.
According to the American Cancer Society, prostate cancer is the second leading cause of cancer death in men with approximately 232,100 new cases and 30,400 deaths in the US in 2005.
The mortality from this disease is expected to rise significantly with the aging of the “baby boomer” generation. The Prostate Cancer Foundation forecasts that without new interventions the number of deaths from prostate cancer in the US will grow to approximately 68,000 annually by 2025.
“Results from the 250-patient phase II ASCENT clinical study showed that DN-101 appeared to improve survival while reducing some of the serious side effects of chemotherapy,” said Dr Howard Scher, chief of the genitourinary oncology service at Memorial Sloan Kettering Cancer Center. “The ASCENT-2 phase III trial is designed to determine if this regimen can improve outcomes for patients with advanced prostate cancer.”