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Orathecin
Achieves Major Milestone in FDA Approval Quest
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Taking
a large step forward in the FDA approval
process, the Stehlin lab remains focused on developing
effective cancer drugs. Pictured above is Albert De
Jesus, chemistry specialist. |
This March, after years of meticulous research and clinical
trials with more than
1,000 patients, the Food and Drug Administration (FDA) accepted
the New Drug
Application (NDA) for Orathecin.
Orathecin is an anti-cancer compound developed by Stehlin
Foundation researchers and patented as 9-Nitro Camptothecin.
This oral chemotherapy agent has been co-investigated by
the Stehlin Foundation and SuperGen Inc. as a treatment
for patients with pancreatic cancer who have failed at least
one prior chemotherapy. The FDA
indicated that November 26, 2004 is the target date for
Orathecin’s review completion
and the action letter for the filed NDA.
“It is a tremendous achievement for any cancer research
laboratory to take a drug all the way from initial development,
through the research, clinical trials, patenting process
and then into the public marketplace,” said Bobby
Anderson, director of the Stehlin Foundation for Cancer
Research. “We do not know of another Houston research
institute that has made it all the way through the process,
and only one in
10,000 drugs under development eventually winds up on pharmacy
shelves.”
Recent statistics suggest a decrease in new drugs receiving
FDA approval.
According to the Journal of Commercial Biotechnology, in
2001, the drug industry
launched only 25 new drugs. An estimated average of $800
million was spent getting one new drug to market.
Pancreatic cancer is the fourthleading cause of cancer death
in the U.S. for men and women. Its 99 percent mortality
rate is the highest of any cancer. This year alone, 31,860
people will be diagnosed with pancreatic cancer and 31,270
will die.
“Our clinical and regulatory teams worked tirelessly
to submit a thorough
and complete NDA and we are gratified that it has been accepted
by the FDA,”
said Dr. James Manuso, chairman, president and CEO of SuperGen.
“Although Orathecin is not a cure, we adamantly believe
that it can be of benefit to some patients with pancreatic
cancer. We are committed to working with the FDA to bring
this drug to market so that it can help the very patients
who need it most.”
With the generous support of caring individuals, corporations
and charitable
foundations, the Stehlin Foundation has made important progress
toward changing the dark prognosis for people with pancreatic
cancer. A growing number of researchers worldwide are validating
the camptothecin compounds’ potential to become the
ultimate standard in the anti-cancer drug class.
“We are pleased that this next step in the long process
toward final FDA approval holds the hope of a brighter future
for patients and families battling pancreatic and other
forms of cancer,” Anderson said.
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