Clinical Trials - Riquent™

Clinical Trials

Lupus Clinical Trial: For information on the ongoing clinical trial entitled "A Randomized, Double-blind, Placebo-controlled, Three-arm, Parallel-group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease" please go to the following website: clinicaltrials.gov

Current Phase 3 Trial

La Jolla Pharmaceutical Company is conducting a placebo controlled Phase 3 clinical benefit trial designed to meet the FDA's requirement that we conduct an additional randomized, double-blind study. The study is being conducted under a Special Protocol Assessment ("SPA"). The SPA process is a formal procedure that results in a binding written agreement between a company and the FDA concerning the design of a clinical trial or other study. The Company expects to activate more than 100 clinical trial sites and complete patient enrollment into the study around the end of 2007.

In contrast previous clinical trials of Riquent, in the current Phase 3 trial, virtually all patients are being treated with one of two higher doses of Riquent or placebo, the number of patients to be studied has been more than doubled, the primary endpoint has been refined, the use of immunosuppressive agents was further restricted, and the treatment duration was changed to 12 months. As in the previous Phase 3 study, patients in the study all have a history of lupus renal disease.

Beginning in February 2007, following further discussions with the FDA, the Company announced that all new patients entering the study will be randomized in equal numbers to receive weekly doses of either 300 mg or 900 mg of Riquent or placebo, with no further patients randomized to the 100 mg dose group. The FDA confirmed that the primary endpoint required to establish efficacy is the time to renal flare for the combined population of patients treated with weekly Riquent doses of 300 mg and 900 mg, compared with placebo.

The study's sample size has been increased to approximately 730 patients which is expected to increase the likelihood of achieving a statistically significant outcome for the individual dose groups when compared with placebo as well as overall. The number of patients to be enrolled is more than twice the approximately 300 patients in the previous Phase 3 study. The trial is designed to be successful based on the results from the last Phase 3 study, where all drug-treated patients received a dose of 100 mg per week of Riquent. In determining how many patients should be enrolled in the current Phase 3 clinical benefit trial, no additional clinical benefit from treatment with doses higher than 100mg was assumed.

In other changes to the study design, the study entry criteria further restricts the use of immunosuppressive agents which, in the previous Phase 3 study, may have reduced the renal flare rate. Also, the current design was changed to a fixed 12-month patient evaluation period. In the previous Phase 3 trial, patients were treated for up to 22 months.

Also, the primary endpoint will be assessed in all patients and will no longer be restricted to the high-affinity subpopulation. The Company believes that the increased binding capability of higher doses will eliminate the need for an affinity measurement prior to treatment.

To increase efficiency and enhance the quality of data, the Company also combined the Phase 2 clinical pharmacology study with the Phase 3 study so that Riquent blood levels will be collected in the same patient population as the definitive efficacy data. These changes were all incorporated into the approved SPA.

To date, Riquent has been well tolerated in the current Phase 3 study. The adverse event profile for all patients in the study, including those treated with the 300 mg and 900 mg doses, does not appear to differ from that seen in previous studies where 100 mg of Riquent was the treatment dose.