A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is a very serious form of cancer. The majority of patients present with
unresectable disease, and the condition is often not diagnosed until the cancer is
relatively advanced. The standard first-line treatment for patients with unresectable
pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to
derive benefit from this treatment. No clinical or molecular marker has been established to
predict benefit from gemcitabine therapy, so patients are treated empirically until evidence
of disease progression or worsening performance status.

The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict
survival in gemcitabine-treated patients has been studied, and data suggest that patients
with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine
treatment than patients with high levels of tumor cell hENT1 expression. These data support
the hypothesis to be tested in this study that patients with pancreatic tumors expressing
low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit
from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.