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La Jolla Pharmaceutical Provides Update on Interim Antibody Results,From Riquent Lupus Phase 3 Trial

SAN DIEGO, March 20, 2007 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company today announced updated interim antibody reduction data for the Phase 3 trial of Riquent(R) (abetimus sodium), its drug candidate for systemic lupus erythematosus ("lupus" or "SLE"). The updated analyses reinforce the previous conclusion that there is a definitive and significant dose response between the 100 mg, 300 mg and 900 mg doses of Riquent compared with placebo (p=0.0001). These interim data were initially announced March 8, 2007.

Dose Dependent Antibody Reduction

The minor changes to the data show a greater reduction from baseline in antibody levels in patients treated with Riquent. The median percent reductions were 100 mg: 18%; 300 mg: 28%; 900 mg: 46% at week 8. In parallel, there was less of an increase above baseline in the antibody levels for the placebo group. As a result, the reductions in median antibody levels between the Riquent treatment groups and the placebo treatment group at week 8 were 100 mg: 30%; 300 mg: 40%; 900 mg: 58% (p=0.0032, p<0.0001, p<0.0001 respectively).

Approximately three times as many patients treated with 900 mg of Riquent (42%) had at least a 50% or greater antibody reduction at week 8 compared with patients treated with 100 mg (13%). Patients reached their maximum reduction after four weeks of treatment at which time separation between doses was also seen.

The analyses assessed the impact of treatment with Riquent on reducing antibodies to dsDNA in 101 patients by measuring the percent of antibody reduction from baseline compared with placebo following weekly treatment with 100 mg, 300 mg or 900 mg of Riquent or placebo. All demographics and baseline characteristics were comparable across dosing groups and there were 16 to 30 patients per treatment group.

Consistent Antibody Reductions

Published data from earlier La Jolla studies indicated tha
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