EntreMed to begin tests of Endostatin in humans

FDA approves trials of anti-cancer drug that starves tumors


July 28, 1999|By Mark Guidera | Mark Guidera,SUN STAFF

EntreMed Inc. said yesterday that it has received permission from the Food and Drug Administration to begin testing one of its much anticipated experimental anti-cancer drugs in humans, and expects the small trial to begin in September.

The Rockville biotechnology company had not planned to seek FDA approval to test its Endostatin protein until September at the earliest. The experimental drug has shown promise in animal studies by blocking tumor growth.

Dr. John W. Holaday, EntreMed's chairman, president and chief executive officer, said the company was able to move up the time frame because of an "aggressive development schedule," which included completing and compiling data from required animal testing earlier than anticipated.

"We have been working around the clock to get this to clinical trials," said Mary Sundeen, a spokeswoman for the company.

Holaday said the company has enough Endostatin on hand for what is called a Phase I trial. In that study, clinical investigators will look for adverse reactions from the treatment in order to make sure it is safe.

If that hurdle is cleared, it could take another three to seven years of human testing to see how effective the drug is before it would be considered for marketing approval by the FDA.

The drug is to be tested on a group of about 40 volunteer patients at DanaFarber/Partners CancerCare Center in Boston, the University of Texas M.D. Anderson Medical Center in Houston and the University of Wisconsin Comprehensive Cancer Center in Madison.

The National Cancer Institute will participate in the studies.

Endostatin has been the subject of debate among scientists and biotechnology analysts, in part because it was portrayed in a New York Times article in May 1998 as a potential "cure" for cancer. That caused shares of the company's stock to leap more than 300 percent in one day. The article has since been widely criticized.

Shares rose $1.9375, or 9 percent, in trading yesterday to close at $22.625.

The protein was discovered by cancer researcher Dr. M. Judah Folkman at Children's Hospital in Boston. He found that it thwarted cancer growth by blocking tumors' ability to grow more blood vessels for nourishment.

EntreMed, which underwrites Folkman's research, licensed rights to the protein and another, similar one, Angiostatin.

Cancer experts note that many new drugs which seem promising in animal studies prove ineffective in human studies and that it is, therefore, too early to tell whether Endostatin will be an effective cancer treatment.

Money-losing EntreMed is one of at least a dozen drug-development companies working on new cancer treatments to block blood vessel growth, or angiogenesis, in tumors.

Several of those companies, including ImClone Systems Inc. of New York, already have experimental treatments in human trials.

Pub Date: 7/28/99

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