Endostatin human trials seen for fall

EntreMed, NCI planning broad tests of anti-cancer drug

3 medical centers sign up

Investigational permit sought to treat advanced tumors


May 18, 1999|By Mark Guidera | Mark Guidera,SUN STAFF

EntreMed Inc. said yesterday that it expects to begin human trials of its anti-cancer drug Endostatin this fall, launching a process that will answer at last whether the experimental treatment is a breakthrough drug for the illness.

EntreMed and the National Cancer Institute, which is assisting EntreMed with the study and development of Endostatin, plan to test the compound on a broad range of cancer patients, as is normally done with promising new cancer treatments. The NCI said it plans to test the drug on patients with advanced solid tumors, including patients diagnosed with cancers of the breast, prostate and colon, as well as lung lymphomas.

EntreMed and the NCI plan to seek clearance from the Food and Drug Administration to conduct early stage, or Phase I, trials of Endostatin under what is known as an Investigational New Drug, or IND, permit.

An IND allows experimental drugs to be tested on patients suffering from a condition or disease for which there are no good treatment options available, rather than on healthy volunteers as is normally done in Phase I trials. In those studies, researchers normally look first for bad side effects.

But under an IND, researchers can also track how patients respond, while making sure the treatment is safe. This can speed badly needed new drugs through the arduous and time-consuming clinical trial process.

"EntreMed is proud to take Endostatin protein into human clinical trials just three years after its discovery," said John W. Holaday, president and chief executive officer of Rockville-based EntreMed.

Three medical centers have agreed to participate in the study, said Mary P. Sundeen, senior director for corporate communications at EntreMed.

Sundeen said the company expects the Dana-Farber Cancer Institute in Boston to be the first center to begin treating patients for the experiment.

The other clinical trial sites are the University of Texas M. D. Anderson Medical Center in Houston, and the University of Wisconsin Comprehensive Cancer Center in Madison.

EntreMed and the NCI expect to sign up between 15 and 30 patients at each trial site.

"We don't expect to have any trouble enrolling patients for the trials, given the publicity it has had," said Sundeen.

Much of that attention is the result of a highly controversial front-page article in the New York Times article last May. That article depicted Endostatin as a potential cure for cancer, and the discoverer, M. Judah Folkman of Harvard Medical Center, as on a track to "cure cancer in two years."

The story caused widespread speculation on EntreMed's stock the day it appeared. Shares shot up nearly 330 percent to nearly $52. More than 23 million shares traded hands.

Yesterday, shares in EntreMed rose 18.75 cents to close at $24.6875.

More than 1,200 people called the company after publication of the Times article and asked to be put on a list for clinical trials, said Sundeen. EntreMed's drug, licensed from Harvard and Folkman, is known as an angiogenesis inhibitor.

It is designed to block the formation of new blood vessels, cutting off tumors' supply of oxygen and nutrients, and hence their growth and spread to other areas of the body.

Dr. James Pluda, a senior investigator with the NCI, said Endostatin is "one of many" angiogenesis inhibitors that show promise.

According to the NCI, there are about 20 experimental angiogenesis inhibitors in human studies in the United States.

Sundeen at EntreMed urged cancer patients interested in participating in clinical trials of experimental treatments to consider enrolling for other trials, rather than waiting for the EntreMed study. The NCI's clinical trials information line, 1-800-4-CANCER, has information on trials currently enrolling patients, she said.

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