Banned sedative gets new chance Md. firm helping test thalidomide as a cancer treatment HTC

April 05, 1996|By Mark Guidera | Mark Guidera,SUN STAFF

EntreMed, a small Rockville biopharmaceutical company, and drug giant Bristol-Myers Squibb Co. have jointly launched the first human clinical trials in the United States to determine whether thalidomide, the sedative banned decades ago because causes birth defects, may provide a dramatic new way to treat cancer.

If that proves true, the drug, which triggered a mountain of lawsuits in the 1950s, could become a big profit generator again, say pharmaceutical industry analysts.

Critical Phase II trials are being launched this month at three medical institutions, Georgetown University Medical Center in Washington, the National Institutes of Health's Clinical Center in Bethesda and the Dana-Farber Cancer Institute in Boston. Between 15 and 30 cancer patients will be enrolled at each trial site.

Cancer experts at the National Cancer Institute in Bethesda, which is overseeing the studies, said they are the only human clinical trials in the United States aimed at determining the anti-cancer effects of thalidomide.

"This is a very exciting field of research," said William Dunnett, spokesman for Bristol-Myers Squibb, considered a leader in the development of oncology treatments.

L EntreMed officials were not available for comment yesterday.

Thalidomide's effects on people with breast, prostrate and brain cancer and Kaposi's sarcoma, an abnormal growth common among those with AIDS, will be studied, the NCI said.

About 500,000 new cases of those diseases are diagnosed in the United States annually, according to the American Cancer Society.

Thalidomide has been the focus of much medical research lately as a potential treatment for a wide range of diseases.

In August 1995, the FDA approved Synovir, a thalidomide drug, for use as an experimental therapy for some patients experiencing the late-stage "wasting" complication of AIDS. That approval was given to Celgene Corp. of New Jersey. Thalidomide is also sold in South America and Europe as a treatment for leprosy.

If the results of the trials being started this month show promise, EntreMed and Bristol-Myers Squibb will have to conduct another study -- called a Phase III trial -- with a much larger population of patients, and then seek marketing approval from the Food and Drug Administration. Those steps could take up to seven years.

Should 4-year-old EntreMed and Bristol-Myers be successful in their joint research effort to get a product approved for use in the United States, EntreMed could expect $20 million to $50 million in royalty revenues, based on industry averages, said Alex Zisson, a pharmaceutical industry analyst with Hambrecht & Quist.

Mr. Dunnett at Bristol-Myers Squibb said it was too early to estimate what the cost of the Phase II studies would be.

But industry experts said the approval process for the drug should be significantly lower than industry averages for getting a new product approved because thalidomide's development costs and toxicity tests were paid for by companies that developed the drug in the 1950s.

The studies seek to determine if thalidomide and several related compounds could be used to prevent the abnormal formation of blood vessels, which cancer experts have long known contributes to cancer cell growth.

The role of blood and blood vessels in disease -- an emerging field of medicine called angiogenesis -- has caught the eye of every major pharmaceutical company, said industry analysts.

EntreMed's research has focused on thalidomide's potential for specifically targeting and blocking the growth of primary and metastatic cancers by eliminating a tumor's blood supply.

Conventional treatments used to control cancer cell growth, such as radiation and chemotherapy, do not target cancer cells specifically; they also kill off other cells, resulting in side effects and complications.

Dr. Sol Rajfer, senior vice president for worldwide clinical research at Bristol-Myers Squibb, said that research by EntreMed and other other companies "clearly shows that antiangiogenic drugs are an especially promising and innovative approach to cancer treatment.`

EntreMed licensed pioneering research on angiogenesis from Dr. Judah Folkman, the director of the Surgical Research Laboratory at Children's Hospital in Boston.

In December, Bristol-Myers Squibb announced an agreement in which it obtained exclusive worldwide licensing rights to certain antiangiogenic compounds developed by EntreMed.

Pub Date: 4/05/96

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