Anti-tumor drug offers ray of hope

Angiostatin's tests for safety in humans suggest it may help

Disease was stabilized

More trials needed to determine if drug slows cancer growth

October 31, 2001|By Julie Bell | Julie Bell,SUN STAFF

MIAMI BEACH, Fla. - EntreMed Inc.'s experimental anti-cancer drug Angiostatin showed what could be early signs of effectiveness in patients who injected themselves with the drug at home, much like diabetes patients taking insulin, scientists reported here yesterday at an international conference on cancer research.

Tumors didn't shrink dramatically in any of the 24 patients participating in a Phase I clinical trial in the Netherlands. But a number of patients' diseases had stabilized for months - no new tumors were detected while existing ones grew no more than 25 percent.

Sixteen patients were able to stay on the drug for more than five months, meaning their tumors didn't grow more than 100 percent during that period - growth that would have disqualified them from continuing to take the medicine.

The results, achieved in patients with advanced cancer who already had undergone approved treatments to no avail, give EntreMed executives and independent scientists overseeing the trial hope that they are seeing the earliest signs of what could be the future of cancer treatment: Nontoxic drugs that turn the disease into a long-term but manageable illness.

"I'm very excited about it," said Edward R. Gubish, EntreMed's president and chief operating officer.

Dr. Emile Voest, the principal investigator overseeing the trial in Utrecht, described the results as "hopeful."

But he and co-investigator Laurens Beerepoot warned against making too much of the results, noting that a Phase I trial is designed primarily to test whether a drug is safe, not whether it is effective.

"We are excited that we see people having a long-term non-toxic drug," Beerepoot said. Whether the disease was stabilized by the drug is hard to say, he said.

Voest said he is anxious to expand testing of Angiostatin after six of the first 16 patients to enroll had stable disease after three months' treatment and five of those patients remained stable after five months.

He said six patients, two of whom have stable disease, continue to take the drug. One of those with stable disease has been on Angiostatin since the trial began in December 2000.

Results of the Phase I trial, the first of three stages of human testing required by the Food and Drug Administration, were presented at the Molecular Targets and Cancer Therapeutics conference sponsored by the American Association for Cancer Research, the National Cancer Institute and the European Organization for Research and Treatment of Cancer.

Angiostatin is one of a new class of nontoxic drugs designed to fight cancer by blocking the growth of tumor-feeding blood vessels.

Dozens of EntreMed's competitors also presented results from animal and early human tests at the conference.

Scientists also presented research yesterday showing that Endostatin, another anti-cancer drug being developed by EntreMed, did not result in any toxicity in patients when given in a separate Phase I clinical trial in the Netherlands using two different methods.

In that test, 20 patients took the drug for four weeks through a system that pumped the drug continuously into a vein. The patients then switched to injections they gave themselves. The Rockville drug maker plans to expand that trial, adding 12 patients who will take a more concentrated form of the drug.

Wall Street continues to take a wait-and-see attitude toward EntreMed and its three anti-cancer drugs in human testing, all of which are designed to fight cancer without side effects by blocking the growth of tumor-feeding blood vessels.

Shares of EntreMed fell 66 cents yesterday, or about 5 percent, to close at $11.85 on the Nasdaq stock market.

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