MedClone Inc. said it plans to file an investigational new drugapplication in the third quarter for its first product, a vaccineto treat lupus nephritis.

Lupus nephritis is an autoimmune disease in which patientsproduce an anti-self antibody that causes kidney damage,ultimately leading to loss of kidney function. The vaccineconsists of a murine monoclonal antibody, 3E10, which isdesigned to elicit an immune response.

"If you intradermally immunize patients with the pathogenicantibody, that induces the production of anti-idiotypes whichbind to the auto-antibody," said Peter Ulrich, president andchief executive of the privately held Los Angeles company."The bound complex no longer binds to the kidney. It alsoseems to inhibit the production of more pathogenic antibodiesfor reasons that aren't understood."

Animal data published in the April 1990 Journal ofImmunology indicated that immunization of lupus mice withthe MAb inhibited production of native antibodies, suppresseddevelopment of lupus nephritis and induced production of anti-ids.

At 6 months of age, 10 of 13 immunized mice were alive,compared with two of 14 and five of 15 mice in two controlgroups.

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