MedClone Inc. announced that it has received orphan drugdesignation for a potential monoclonal-antibody based therapyfor kidney disease associated with lupus, the second mostprevalent systemic autoimmune disease after rheumatoidarthritis.
There are about 250,000 to 300,000 cases of systemic lupuserythematosus in the U.S., Peter Ulrich, MedClone's presidentand chief executive officer, told BioWorld. About half thosecases have nephritis, a potentially life-threatening conditionwith 35 percent mortality within 10 years of diagnosis and 15percent within five years.
MedClone, a privately held biopharmaceutical company basedin Los Angeles, is the only company focusing on using anti-idiotype vaccines in auto-immune diseases, Ulrich said.
These vaccines elicit an antibody to an antibody, and couldpotentially regulate flare-ups of lupus, which has episodes thatmight be regulated by the immune system. "We want to try toflatten the line of the ebb and flow of the disease," Ulrich said,"and stabilize the braking mechanism of the immune system."
Nephritis develops when the immune system attacks anddamages kidney tissue, but results in a mouse model of thedisease shows that injecting an anti-idiotype between the skinand the muscle can down-regulate the condition.
Ulrich added that Idec and ImClone are working on anti-idiotype vaccines in cancer, in which the body is stimulated tocreate antibodies to tumor antigens through injection of anantibody to a naturally occurring antibody the patient producesto the cancer cell.
This "much tougher" approach has already been taken intoclinical trials, he added.
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