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We are developing Asentar 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 AIPC, by adding
Asentar to the treatment regimen.
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 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 secondary endpoint. In addition, we observed a reduced incidence
of serious adverse events in patients receiving Asentar . 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 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.
We believe that Asentar may offer the following therapeutic and commercial
benefits:
- clinically meaningful overall survival improvement and favorable
safety profile in patients with AIPC;
- anti-cancer activity in multiple tumor types, including prostate,
breast and colon, as suggested by pre-clinical data;
- enhanced anti-cancer activity with multiple chemotherapy agents, as
suggested by pre-clinical data;
- novel mechanism of action via a nuclear receptor, a member of a proven
family of targets for drugs;
- convenient, proprietary high-dose oral pill; and
- exclusive worldwide rights protected by a multi-layer patent portfolio
with significant remaining patent life.
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