EntreMed to widen testing of key drug

Anti-cancer therapy passes safety hurdle in Philadelphia human trial

May 21, 2002|By Julie Bell | Julie Bell,SUN STAFF

EntreMed Inc. said yesterday that it plans to move its anti-cancer drug Angiostatin into additional clinical trials later this year after it proved safe, both when used alone and when used in combination with radiation.

The Rockville company presented final results yesterday from a human test of the drug in combination with radiation at Thomas Jefferson University Hospital in Philadelphia.

The results showed that Angiostatin did not increase the toxic side effects of radiation -- safety results that were the major goal of the study.

But the trial did little to illuminate whether the drug will help enhance radiation's effects against cancer.

"I would think [the results] are comparable if not a little bit better than radiation alone," EntreMed President Edward R. Gubish Jr. said, hastening to add that the study wasn't designed to compare the two. Just how the combination works to fight cancer will have to be the subject of future studies -- if EntreMed chooses to do them.

Yesterday, Gubish said the company plans to continue to test Angiostatin alone or in combination with other treatments.

One of the trials planned for later this year probably will test the drug in combination with chemotherapy, "most likely in individuals with lung cancer," he said.

The radiation with Angiostatin trial was the subject of an occasional series last year in The Sun. The newspaper followed cancer patients enrolled in the trial, doctors overseeing it and company executives and scientists to illustrate the complex process involved in a company's attempt to bring a biotech drug to market.

Angiostatin is one in a new class of dozens of drugs that are designed to fight cancer by blocking the growth of tumor-feeding blood vessels. The hope is that the drugs will prove less toxic than traditional cancer therapies, allowing patients to undergo treatments with fewer side effects.

The final Phase I clinical trial results released yesterday at the American Society of Clinical Oncology meeting in Orlando, Fla., showed a total of 23 patients enrolled in the Angiostatin with radiation trial. Six dropped out or were not available for evaluation, leaving 17 who were evaluated for a response. Of the 17, 11 had "measurable disease," meaning tumors that could be measured to see if they shrank.

Ten of these patients -- or nearly 91 percent -- had partial or complete tumor shrinkage in the areas targeted by radiation, study results presented yesterday showed. Eight of the 10 had partial tumor responses, meaning the tumor targeted by radiation shrank at least 50 percent.

The remaining six had "evaluable disease," meaning their tumors couldn't directly be measured because CAT scan images of them were partially obscured by bones or organs. Two of these patients showed improvement during the trial, while four experienced no change.

"As radiation oncologists, we are always searching for innovative ways to improve the effectiveness of radiation therapy without additional side effects that further diminish patients' quality of life," Adam Dicker, a Thomas Jefferson radiation oncologist who played a key role in overseeing the clinical trial, said in a statement. "The results from this combination Angiostatin-radiation trial could be the first step towards such a treatment."

Shares of EntreMed lost 81 cents yesterday to close at $6.99 on the Nasdaq stock market.

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