U.S. OKs 1st test of drug for lupus

Human Genome find might treat broad range of diseases

November 02, 2001|By Julie Bell | Julie Bell,SUN STAFF

Human Genome Sciences Inc. said yesterday that it received government clearance to begin human testing of a drug that holds promise for treating a range of diseases - including some forms of arthritis and lupus - in which an overstimulated immune system attacks the body.

The drug, known as LymphoStat-B, will be tested first in patients with systemic lupus, an incurable, potentially fatal immune disorder that the Lupus Foundation of America estimates afflicts at least 500,000 Americans.

People with systemic lupus erythematosus, as the disease is known, suffer a range of symptoms, including fatigue, swollen joints and rashes.

Lupus patients ultimately can develop kidney failure, heart and lung inflammation and blood disorders. The disease traditionally has been treated with anti-inflammatory drugs and other medicines that weren't specifically developed for lupus.

Human Genome Sciences used computers to identify the genes that produce the therapeutic proteins in LymphoStat-B.

The Rockville company intends to develop the drug to fight other so-called autoimmune disorders, including rheumatoid arthritis - a disease that afflicts more than 2.5 million people in the United States.

The company said yesterday that the Food and Drug Administration had granted its application to begin clinical trials of LymphoStat-B as a potential new treatment for autoimmune diseases.

"As a family, these diseases cause immense suffering to millions of patients worldwide," said William A. Haseltine, Human Genome's chairman and chief executive officer, in a statement. "LymphoStat-B provides a new, fresh, rational, mechanism-based approach for the treatment of these diseases."

Autoimmune disorders, such as systemic lupus, are characterized by elevated levels of a protein known as BLyS in their blood and joint fluid, the company said. BLyS stimulates B lymphocyte cells to develop into plasma B cells, which produce infection-fighting antibodies.

More antibodies are a good thing in patients whose immune systems aren't active enough, but in people with autoimmune disorders, Human Genome scientists believe, too much BLyS can be bad, prompting the body to be attacked by its own immune system.

LymphoStat-B, informally dubbed "anti-BLyS" by company insiders, binds to BLyS and blocks it from promoting the development of B cells and antibodies.

Human Genome Sciences also is testing BLyS as an immune-system stimulant to treat people with immune deficiencies.

LymphoStat-B is the sixth drug Human Genome Sciences will have in human testing. But it is the first developed by the company to use a monoclonal antibody, one that binds to just one target, like a key in a lock.

Haseltine also said that the human tests of LymphoStat-B are the first for an antibody drug discovered through gene-searching computers. As such, he said, it "represents a new era in medicine."

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