In collaboration with Schering Plough, we are developing Asentar™ (DN-101) as a novel, oral anti-cancer agent. Asentar has the potential to be an effective therapy against multiple tumor types and could be used in combination with multiple chemotherapy agents. Our initial development efforts seek to improve the clinical benefits of Taxotere®, also known as docetaxel, the current standard of care for the first-line treatment of androgen-independent prostate cancer (AIPC). We have also initiated a Phase 2 trial to evaluate Asentar's potential in advanced pancreatic cancer.
We have completed a 250-patient Phase 2/3 clinical trial, known as ASCENT, which evaluated Asentar in combination with once-weekly Taxotere compared to once-weekly Taxotere alone in patients with AIPC. In this trial, we observed a consistent trend in favor of Asentar across all efficacy endpoints, although the primary endpoint, prostate specific antigen response, or PSA response, did not achieve statistical significance. However, the Asentar arm demonstrated a clinically meaningful improvement of 49% in overall survival versus Taxotere alone in a pre-specified secondary endpoint. In addition, we observed a reduced incidence of serious adverse events in patients receiving Asentar. The most common adverse events observed with Asentar included low-grade elevation of calcium and creatinine in the blood. One case of kidney stones was also reported.
We believe that it is potentially significant that the survival benefit from use of Asentar was achieved without an increase in toxicity. We seek to confirm these survival and safety benefits of Asentar in our ongoing 900-patient ASCENT-2 Phase 3 clinical trial. In addition to our studies in AIPC, we are also planning to investigate the use of Asentar in earlier stages of prostate cancer (androgen-dependent prostate cancer and adjuvant prostate cancer) and in other tumor types.
For more information on ASCENT-2, click here.
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David Copeland, D.M.D., was one of the patients enrolled in the ASCENT Phase 2 trial. Historically, those with AIPC have had few available options. The participation of David and others like him in the ASCENT trial has helped to further research that can potentially have a positive impact on those with AIPC and other types of cancer.
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