EntreMed says drug still on track Firm reacts to report questioning results of endostatin tests

Stock price plunges

Company planning human trials in '99 for anti-cancer agent

Biotechnology

November 13, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

EntreMed Inc. said yesterday that plans to get one of its experimental anti-cancer drugs into human trials next year remain on track despite a published report that cancer experts have been unable to verify test results showing it shrinks tumors in mice.

Shares in the Rockville-based biotechnology company plunged $7.75 -- more than 23 percent -- to $24.875 as investors reacted to a front-page Wall Street Journal article. More than 2.8 million shares traded hands, about 50 times the average trading volume.

This is the second time in six months that published reports about the EntreMed drug, endostatin, have sent its shares on a wild ride.

In May the company's share price rocketed from $12 to $85 in a single day before closing at $51.81 after a front-page Sunday New York Times article portrayed the work of cancer researcher M. Judah Folkman and EntreMed's experimental compounds as a potential cure for cancer.

Yesterday's article focused on researchers' attempts to duplicate endostatin studies by Folkman, of Children's Hospital in Boston, that showed it shrank tumors in mice by choking off the tumors' blood supply.

"The problem with this story was it was based on a snapshot in time," EntreMed Chief Executive Officer John Holoday said yesterday of the Journal article.

Holoday said it takes considerable time and effort for scientists to reproduce test data. "It usually takes about a year and a half, and that's the fastest to be expected. The wheels of science move slowly," he said.

Holoday said that data from recent studies by a Swedish researcher and researchers at pharmaceutical companies interested in endostatin using a humanized version of the agent showed that it is effective. He said data from some of those studies should be published next year.

"To us, nothing has changed a bit. We are proceeding with our plans to develop endostatin. It's still on track for testing in humans next year," said Holoday.

Folkman was not available for comment yesterday, but Holoday said the researcher was feeling "very dejected" about the Journal article. "It's a frontal assault on his credibility," Holoday said.

EntreMed licensed rights to endostatin and another protein-based drug, angiostatin, from Folkman and Children's Hospital in Boston. The Rockville company continues to hold marketing rights to endostatin, but licensed rights to angiostatin to drug giant Bristol Myers Squibb in 1995. Bristol Myers has not announced any plans for human trials of angiostatin.

Under the licensing deal with EntreMed, the company paid more than $1 million in initial funding to support Folkman's research on Thalidomide, the banned sedative that has shown promise in treating cancer and other diseases. EntreMed licensed rights to the drug in treating solid tumors, and it is now in a clinical trial to assess its effectiveness.

The agreement was later extended to include rights to endostatin and angiostatin. EntreMed agreed to support Folkman with another $10 million in research funding. The agreement expires in April 1999.

Yesterday, the National Cancer Institute, which has been working on endostatin with EntreMed under a government research agreement, issued a statement in response to reporters' inquiries about its studies on endostatin.

NCI said that while preliminary studies on endostatin showed the bTC drug caused "slight delays" in the growth of lung tumors in mice, follow-up studies using both mouse and human forms of endostatin "have not produced the marked regression of these tumors in mice that Folkman's laboratory has reported."

The NCI said it plans to send scientists to Folkman's laboratory in Boston later this month to compare notes about each other's studies and the batches of endostatin that each has been using.

Experts note that one or more of a host of complex issues could be causing NCI study results to come out differently from Folkman's, ranging from improper production techniques to a breakdown of endostatin's molecules from handling or transportation.

Folkman told the Journal that he thought other scientists may have been having difficulty replicating his results because the endostatin molecule is large and requires an acquired skill to work with properly.

These experts say the key is to ensure that the best endostatin molecule possible is the one that goes into human studies.

Yesterday, EntreMed said it stands "solidly behind the data demonstrating the potent effects" of endostatin and angiostatin.

Mary Sundeen, vice president for research at EntreMed, noted that the company would not have signed an agreement with Covance Biotechnology Services Inc. of North Carolina to produce large quantities of endostatin for human studies if the drug didn't hold promise.

EntreMed is not the only company attempting to develop drugs to turn off the ability of tumors to grow blood vessels, a process called angiogenesis. The NCI estimates that more than a dozen experimental agents which aim to control or kill off tumors by turning off blood vessel growth are in clinical trials.

Pub Date: 11/13/98

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