Mandy - Lupus Foundation Article on Lymphostat-B

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Words of Caution

Positive Results of Phase I Study Put LymphoStat-B on Fast Track for Drug Development

-

Human Genome Sciences, Inc. of Rockville, MD,

has announced that results from its Phase 1 clinical trial of

LymphoStat-B show the therapy to be effective and well-tolerated in

adults with lupus. The Federal Drug Administration (FDA) has approved

LymphoStat-B as a Fast Track Drug for the treatment of lupus.

The

Fast Track Drug Development Program was designed by the FDA to speed

the review of new therapies that demonstrate the potential to have a

positive effect on unmet medical needs. Human Genome Sciences has plans

to start a Phase 2 clinical trial of LymphoStat-B for the treatment of

lupus and rheumatoid arthritis later this year.

LymphoStat-B

is an antibody that stimulates the development of plasma B cells.

Plasma B cells produce antibodies that protect the body from infection.

In autoimmune diseases such as lupus and rheumatoid arthritis, excess

numbers of these antibodies attack and destroy healthy tissues.

In

earlier studies, Human Genome Sciences discovered that a protein named

BLyS stimulates cells to develop these plasma B cells. High levels of

BLyS can contribute to autoimmune disease. For example, individuals

with lupus are believed to have higher than normal levels of BLyS in

their bodies. Early research showed that LymphoStat-B could stop this B

cell activity.

The

Phase 1 clinical trial of LymphoStat-B was designed to test the

safeness of the therapy in in adults with lupus. Seventy randomly

selected patients were divided into three groups: Two groups were given

different doses of LymphoStat-B, and the third group was given placebo. No

drug-related adverse reactions or negative drug-related side effects

were reported from the new drug. In addition, results showed that

LymphoStat-B can reduce the levels of B cells which can go on to

produce abnormal antibodies.

Lupus

can cause a number of health effects, including pain, fatigue, fevers,

swollen joints, skin rashes, sun sensitivity, and chest pains. The

symptoms mimic other illnesses, and can go into periods of remission,

which makes lupus difficult to diagnose. There is no cure for lupus,

and lupus can be fatal in some cases.

For additional information on LymphoStat-B, go to www.hgsi.com/products/LSB.html

Latest News

Study Shows Promise of New Treatment for Lupus Nephritis Human Genome Sciences Recruiting Patients for Phase II Clincial Study of LymphoStat-B La Jolla Pharmaceutical Presents Additional Riquent® Results LUPUS GENETICS STUDY SEEKS HEALTHY PARTICIPANTS The

goal of the study is to determine which genes cause lupus. This

discovery would pave the way for more focused treatments that could

narrowly target the symptom or its cause with greater efficiency

thereby reducing side-effects. National Institutes of Health Clinical Center Seeks Candidates for Autologous Stem Cell Transplant Study Patients

between 15 and 40 years of age with severe SLE affecting a major organ

that is resistant to standard treatment may be eligible for this study.

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