In collaboration with Schering Plough, we are developing Asentar™ (DN-101) as a novel, oral anti-cancer agent which we expect 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). We have also initiated a Phase 2 trial to evaluate Asentar's potential in advanced pancreatic cancer. 

Through our collaboration with Schering Plough, the Asentar development plan calls for the funding of clinical trials and regulatory filings in earlier stages of prostate cancer (androgen-dependent prostate cancer and adjuvant prostate cancer) and in other tumor types.

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. A summary of key ASCENT 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 elevations 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 in our ongoing 900-patient ASCENT-2 Phase 3 clinical trial. If we confirm our Phase 2 findings in the Phase 3 trial, we believe Asentar may offer the following therapeutic benefits:

• Clinically meaningful overall survival improvement and favorable safety profile in patients with AIPC
  
• Novel mechanism of action via a nuclear receptor, a member of a proven family of targets for drugs

Artist's rendering of how Asentar can potentially help eliminate cancer cells. An oral, intermittent, dose-intense formulation of calcitriol and the most potent natural activator of the vitamin D receptor, Asentar works via a unique mode of action, targeting multiple genes to promote cancer cell death.

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