Wallace Rheumatic Study Center Treats Patients in International Clinical Trial of Lupus Therapy Using a New Therapeutic Approach Called Tolerance Technology.

Business Editors & Health/Medical Writers

LOS ANGELES--(BW HealthWire)--April 11, 2001

The first of up to 300 participants selected to take part in this international clinical trial are being treated with a new therapy known as Toleragens(R).

This therapy is designed to arrest the production of disease-causing antibodies without suppressing the healthy functions of the immune system. Daniel Wallace, M.D., from the Wallace Rheumatic Study Center, a rheumatology research center, was selected as a lead physician to begin enrollment of individuals suffering from lupus kidney disease. This large-scale Phase III trial is evaluating the potential of LJP 394 to prevent or delay renal flares, reduce the need for treatment with high-dose corticosteroids and/or chemotherapy drugs and improve a patient's quality of life.

Lupus is an antibody-mediated, autoimmune disease affecting approximately one million individuals in the United States and Europe. A chronic life-threatening condition, lupus occurs most commonly in women, who usually develop the disease in their childbearing years. The most common treatments -- high doses of corticosteroids and/or chemotherapy drugs -- have not changed in the last three decades. These drugs are toxic and suppress the entire immune system increasing the opportunity for serious infections, fragile bones, hypertension, sterility and cataracts.

"We look forward to offering patients a treatment option that can potentially reduce the number of renal flares caused by this disabling disease," said Dr. Wallace. "Perhaps this treatment can help lupus patients remain functional and active." LJP 394 uses Tolerance Technology to build Toleragens, a class of therapeutics that are designed to arrest the B cells that produce disease-causing antibodies by binding to receptors on targeted B cells. This action delivers a specific and potent "off" signal that causes them to become inactive or to die. LJP 394 could provide physicians with an entirely new weapon against lupus kidney disease. This drug candidate is being developed by La Jolla Pharmaceutical Company.

The Phase III trial will involve individuals with a diagnosis of systemic lupus erythematosus (SLE) who also have a history of kidney disease. Individuals interested in learning more about this trial are encouraged to call 888/30-LUPUS (888/305-8787).