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Company Abstracts :: 2001 :: Selected
Company Abstract
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CLINICAL
AND PHARMACOLOGICAL EXPERIENCE WITH LJP-394
Wallace DJ
LJP-394 is a synthetic biological with immunomodulatory functions.
Composed of four double-stranded oligodeoxynucleotides attached
to a central branched platform, the drug acts as an anti-"anti-ds-DNA"
B-cell toleragen by rendering specific B-lymphocytes unresponsive
to immunogen so they do not produce autoantibodies. Extensive animal
studies and Phase II clinical trials suggested that the effects
of LJP-394 are effective and safe when used as a weekly dose of
100 mg intravenously. Analysis of a multicentre, international Phase
II/III clinical trial showed that patients with lupus nephritis
and high affinity IgG antibodies to LJP-394 have clinical benefits.
This includes increased time to renal flares, reduced number of
renal flares, time to institution of high-dose corticosteroids and/or
cyclophosphamide and lower anti-ds-DNA levels. A definitive trial
is in progress. LJP-394 appears to be free of serious adverse reactions.
Though promising, the role of LJP-394 in patients with active, organ-threatening
lupus is still not known.
Published in
Expert Opinion on Investigational Drugs
2001 Volume 10: pp. 111-117
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