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Dana-Farber to try promising treatment
Entremed Inc., which makes endostatin, yesterday said it had received
clearance from the US Food and Drug Administration to begin a Phase I trial, in
which a drug is tested for safety, in patients at Dana-Farber in the early fall.
''It's very safe to say we're within a 60-day window'' of beginning the
trial, said Mary Sundeen, a spokeswoman for Entremed in Rockville, Md.
However, a Dana-Farber spokesman said the institute will not begin recruiting
patients until its protocol, or official plan for the trial, has been reviewed
and approved by two internal panels. At that point, he said, the cancer
institute will post information about patient recruitment on its Web site at
www.dana-farber.net.
About 100 patients will be enrolled in the trial at Dana-Farber and two other
centers, the M.D. Anderson Cancer Center in Houston and the University of
Wisconsin in Madison, for the Phase I studies. The Dana-Farber study is
sponsored by Entremed; the other two by the National Cancer Institute.
Endostatin is the most powerful of a class of substances called angiogenesis
inhibitors. It was discovered in the laboratory of Dr. Judah Folkman at
Children's Hospital and licensed to Entremed for development.
Folkman and his colleagues have led the study of angiogenesis, the process by
which small cancers recruit a life-support system of small blood vessels from
nearby tissues in the body. Without the nourishment supplied by these vessels,
the tumor cannot grow or metastasize.
Anti-angiogenic substances like endostatin attack and destroy these small
vessels, causing the tumors to shrink or even disappear, yet don't directly
target the tumors. This strategy avoids the common problems of harsh side
effects seen with standard cancer drugs. Also, the tumors do not become
resistant to angiogenesis inhibitors, as they do with drugs that are designed to
poison the tumors.
A number of angiogenesis inhibitors are in early testing in humans, but none
are as potent as endostatin is believed to be.
The Phase I trials are designed to look for toxic effects, she said. But
''should we see a biological response in a patient during the safety testing,
they will have the option to continue taking the drug outside the study,'' and
the company will supply it, she said.
dvanced cancer
patients could begin receiving the promising tumor-starving drug endostatin at
Dana-Farber Cancer Institute within 60 days, according to the biotech company
sponsoring the first human tests of the compound.
This story ran on page B2 of the Boston Globe on 07/28/99.
© Copyright
1999 Globe Newspaper Company.
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