La Jolla Pharmaceutical Co., which began trading publicly in June, hasfiled an investigational new drug application with the FDA to beginhuman clinical trials of its lead compound for treatment of lupus.Andrew Wiseman, La Jolla Pharmaceutical's director of businessdevelopment, said the San Diego-based company expects to beginPhase I safety trials of the drug, called LJP 394, by the end of the year.The clinical trials will be the first for La Jolla.LJP 394 is a compound developed through the company's ToleranceTechnology, which is designed to make molecules that bind to thesurface of B cells and shut off their production of disease-causingantibodies in certain autoimmune diseases.Wiseman said LJP 394 targets B cells that produce antibodies to doublestranded DNA. Those antibodies are believed to cause destruction ofthe kidneys, which can result in death for lupus patients.He added that, as far as he knows, La Jolla Pharmaceutical is the onlycompany using technology to selectively suppress pathogenicantibodies for treatment of lupus.Preclinical trial results involving mice, the company said, showed LJP394 reduced production of anti-double stranded DNA antibodies by 60percent to 96 percent; reduced antibody forming cells by 60 percent;reduced kidney disease by 90 percent; and extended survival by 100percent to 150 percent.Wiseman said two kinds of therapies now are used to treat lupus,steroids and cyclophosphamide, and both can have serious side effects.According to the Lupus Foundation of America, in Rockville, Md., thedisease afflicts more than 500,000 people _ most of them women _in the U.S. and 16,000 new cases are reported each year.In addition to its Tolerance Technology, La Jolla Pharmaceutical isdeveloping a Suicide Inhibitor Technology aimed at irreversiblyinhibiting enzymes involved in the inflammatory process.The company's stock (NASDAQ:LJPC) closed Tuesday at $5.25, up25 cents. _ Charles Craig
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