NEWS: HGS Arthritis Drug Clears Testing Hurdle

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HGS Arthritis Drug Clears Testing Hurdle

Treatment Reduced Symptoms in Study

By S. Rosenwald

Washington Post Staff Writer

Wednesday, April 6, 2005; Page E05

Human Genome Sciences Inc.'s treatment for rheumatoid arthritis has

cleared a major testing hurdle, according to company officials, marking

the first time one of the drugs developed by the Rockville firm has

proved effective in patients.

Results of a recently completed study show that LymphoStat-B reduced

signs and symptoms of the often debilitating disease in 31 percent of

283 patients after six months of treatment. The results set the stage

for broader-scale testing of the drug, the final step before seeking

regulatory approval and bringing the drug to market.

The company has had two other drugs fail in initial human testing since

its founding in 1992.

Later this year, the company is expecting test results to determine

whether the drug helps patients with lupus, another inflammatory

disease that affects mostly women and causes severe joint pain and

fatigue, among other symptoms.

While several treatments are approved for rheumatoid arthritis, there

are none for lupus, which analysts have said makes that upcoming round

of tests even more important for the company.

Chief executive H. Watkins said the company's plans for the drug

depend on further analysis of the study data with federal regulators,

disease specialists, and GlaxoKline PLC, which has the option to

split development costs and profits for the drug.

Human Genome executives did not rule out the option of seeking

regulatory approval for just lupus treatment, particularly because the

rheumatoid arthritis market is so competitive.

Company scientists began developing LymphoStat-B in the late 1990s,

when they discovered a protein called BLyS, which is required for

disease-fighting cells to mature and produce antibodies that attack

viruses and bacteria.

Sometimes those disease-fighting cells instead produce cells that

attack the body's tissue. Most people's immune systems kill those

cells. But many don't, causing autoimmune diseases such as lupus and

rheumatoid arthritis.

Research studies by Human Genome scientists, and others, have shown

that too much BLyS actually causes so much cell activity that the

malicious antibodies thrive and start attacking the body.

LymphoStat-B attacks BLyS and limits the production of those damaging

cells.

http://www.washingtonpost.com/wp-dyn/articles/A28494-2005Apr5.html