MedClone Inc. aims to start by year's end clinical trials of ananti-idiotype vaccine to treat the loss of kidney functionassociated with systemic lupus erythematosus (SLE), apotentially life-threatening autoimmune disease.

The Los Angeles-based company said it filed an investigationalnew drug (IND) application with the FDA for the vaccineagainst lupus nephritis, the kidney problem that afflicts abouthalf of the estimated 500,000 SLE patients in the United States.

The company's research is aimed at developing therapeuticsthat can effectively disrupt the course of specific autoimmunediseases, including rheumatoid arthritis and type 1 diabetes,according to Peter G. Ulrich, MedClone's president and chiefexecutive officer.

In SLE, MedClone's murine monoclonal antibody, called 3E10, isdesigned to spur the patient's own production of anti-idiotypeantibodies. They, in turn, act on the immune system's T cellsand B cells, and disrupt the mechanism of SLE by which thebody's immune system attacks cells lining the tubularpathways of the kidney.

MedClone's strategy is to attack the body's own misdirectedantibodies in such diseases, Ulrich said.

"We have identified common molecular motifs, or structures,which are peculiar to pathogenic autoimmune antibodies," hesaid. These findings, which have not yet been published, couldhelp MedClone sidestep many of the challenges posed byefforts to disrupt earlier stages of the autoimmune progression.If effective, it should at least be an improvement over the useof systemic immunosuppressants to reduce the effects of mostautoimmune diseases, which also reduce the body's ability tofend off disease, Ulrich said.

MedClone is also developing 1C7, an anti-idiotype antibody to3E10. In preclinical studies, it has shown potential as a passiveimmune treatment for sporadic flare-ups of SLE, Ulrich said.Work on a human monoclonal, HRF1, which appears to beinvolved in rheumatoid arthritis, is about one year behind thedevelopment of the lupus treatments, he said.

"We know of no one else who's actually applying anti-id toautoimmune diseases," Ulrich said.

MedClone's technology was developed in the laboratory of itsscientific founder, Richard H. Weisbart, a UCLA medicalprofessor and chief of rehumatology for the UCLA SanFernando Valley Program.

MedClone last fall exclusively licensed rights to two issuedpatents and eight related applications from UCLA, which agreedto take a 5 percent equity stake in the company in return foraccepting reduced royalties on future product sales.

The Phase I study of 3E10 is expected to take about 10 monthsto complete and should involve 12 lupus patients, Ulrich said.MedClone is preparing to apply to the FDA this week for anorphan drug designation, Ulrich said. The company may laterrequest a fast-track review from the FDA.

MedClone was formed in 1986 as a means to direct fundinginto Weisbart's autoimmune research at UCLA. It openedfacilities in West Los Angeles, near the UCLA campus, lastSeptember. Ulrich, a former chief executive officer of LipoGenInc., who mapped MedClone's strategy during a six-month stintas a consultant, came onboard last summer.

MedClone has raised $2.1 million in venture financing, largelyfrom Southern California Ventures of Irvine, Calif. Thecompany, which prepared but never filed for an initial publicoffering filing last spring, is looking to raise about $3 million to$5 million more financing this year, Ulrich said.

-- Ray Potter Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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