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9-NC
Effective in Independent Study
Stehlin Drug Passes Another
Milestone Along the Way to
FDA Approval
The Stehlin Foundation is pleased to join SuperGen in announcing
the
results of independent reviews of the effectiveness of Stehlins
anti-cancer
drug, 9-Nitro-Camptothecin (9-NC).
9-NC, known internally at SuperGen as Rubitecan and now formally
as Orathecin, was developed at the Stehlin Laboratory.
Orathecin (9-NC) is an oral chemotherapy compound in the camptothecin
class and is currently in the concluding stages of Phase III
studies for the treatment of pancreatic cancer. Pending successful
results from the Phase III studies, SuperGen anticipates filing
a New Drug Application with the FDA in 2002. Pancreatic cancer
is associated with high patient mortality causing more than
75,000 deaths annually in the United States and Europe. It
is the fourth-leading cause of death by cancer in the United
States with an average survival rate of four to five months
following diagnosis at an advanced stage.
SuperGen Inc. announces the longterm follow-up and independent
review of results from a previously announced Phase II clinical
study of its oral anticancer compound Orathecin (rubitecan)
has confirmed the drugs activity in patients with refractory
pancreatic cancer who have failed prior treatments. The data,
previously presented at the 2000 Annual Meeting of the American
Society of Clinical Oncology (ASCO), were reviewed by an independent
third-party expert radiology review panel.
"The reviewed results confirm,without question, our belief
that Orathecin is active in heavily pre-treated patients with
advanced refractory pancreatic cancer,"said Dr. Joseph
Rubinfeld, chairman and chief executive officer of SuperGen.
"This is significant because not only do these pancreatic
cancer patients have the worst possible prognosis, but to
show activity in heavily pre-treated patients, with late-stage
disease, is exceedingly difficult."
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