Rockville company testing arthritis drug in Russia Human clinical studies cost much less there

February 17, 1996|By Mark Guidera | Mark Guidera,SUN STAFF

Advanced Biotherapy Concepts, a Rockville biotechnology company, said yesterday that it has launched a small human trial in Russia on a new treatment it has developed for rheumatoid arthritis.

Initially, the company hopes to gather enough strong data on the unnamed drug to entice a major pharmaceutical house to form a strategic alliance with it, said Edmond Buccellato, Advanced Biotherapy's vice president for corporate affairs.

Such alliances are increasingly common in the biotechnology industry. Some biotech companies are finding that they cannot afford the heavy costs of human trials in the United States or Europe, and don't have the experience of seeking Food and Drug Administration clearance for commercialization. But the pharmaceutical houses have wealth in both departments.

Publicly held Advanced Biotherapy, which employs just four people, chose Russia for an early stage clinical study because the cost of human clinical study in the United States or Europe is prohibitive for the cash-strapped firm, said Mr. Buccellato.

Dr. Simon Skurkovich, the company's president and lead researcher, is a Russian immigrant who conducted his early study on the causes of arthritis in his home country before emigrating to the United States.

In the United States, Mr. Buccellato said, the per-patient cost for the trial would be between $20,000 and $30,000. In Russia, the cost would be about $2,000 per patient.

The company will test the drug on 20 patients at the Institute for

Rheumatology in Moscow over the course of several months, he said.

Eventually, however, the company would have to conduct human clinical tests in the United States or Europe if it wants the FDA to consider the drug for market approval here.

The treatment the company is testing is administered by injection. It is made from animal antibodies. The antibodies, the company believes, neutralize substances in the body called aberrant interferons. Interferons are proteins made by the body's cells whose job it is to fight infection.

Aberrant interferons, Dr. Skurkovich believes, trigger auto-immune diseases, such as rheumatoid arthritis, lupus and HIV, the virus that causes AIDS. Auto-immune diseases are caused by abnormalities which trigger the body to act against its own tissue.

Mr. Buccellato said Dr. Skurkovich and others have conducted promising studies on use of the therapy on patients afflicted by rheumatoid arthritis or infected by HIV. But the company has decided to focus its efforts on the treatment of rheumatoid arthritis because the market for treating that disease is potentially larger for the small company, he said.

About 2.1 million people in the United States suffer from rheumatoid arthritis, according to the Arthritis Foundation. It is estimated that Americans spend $55 billion annually on arthritis treatments.

The competition for developing new auto-immune disease treatments is heavy. There are at least 200 new treatments and drugs under study for all forms of arthritis in the United States and Europe, and several major pharmaceutical companies are developing vaccines to combat the HIV virus.

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