In collaboration with Schering Plough, we are developing Asentar™ as a novel, oral anti-cancer agent. We anticipate that Asentar will have applicability to multiple tumor types for use in combination with multiple chemotherapy agents. Our initial development efforts seek to improve upon 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).
Through our collaboration with Schering Plough, we are also looking to investigate the safety and efficacy of Asentar in earlier stages of prostate cancer (androgen-dependent prostate cancer and adjuvant prostate cancer) and in other tumor types such as pancreatic adenocarcinoma.
We have completed a 250-patient Phase 2/3 clinical trial, known as ASCENT, which evaluated Asentar in combination with once-weekly Taxotere versus once-weekly Taxotere alone in patients with AIPC. A summary of ASCENT key endpoints can be seen in the figure below. 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.
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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 the survival and safety benefits of Asentar in our ongoing 900-patient ASCENT-2 Phase 3 clinical trial.
According to the American Cancer Society, prostate cancer is the second leading cause of cancer death in men, after lung cancer, with approximately 232,100 new cases and 30,400 deaths in the United States in 2005. The mortality rate from this disease is expected to rise significantly in the United States with the aging of the “baby boomer” generation. The Prostate Cancer Foundation forecasts that, without new interventions, the number of deaths related to prostate cancer in the United States will grow to approximately 68,000 annually by 2025. AIPC is an advanced stage of prostate cancer and accounts for most of the prostate cancer-specific deaths and much of the morbidity of this disease.
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Click here to download research abstracts and posters on Asentar.
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Through our collaboration with Schering Plough, We Can™ actively research Asentar in a number of different cancers and indications.
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