Wednesday, September 27, 2006
La Jolla Pharmaceutical Company announced today considerable progress on its Phase 3 trial of Riquent® (abetimus sodium) for the treatment of lupus renal disease. Since the August 9, 2006 announcement that the study had been reactivated, the Company has added another 27 clinical trial sites able to screen and enroll patients, for a total of 58 sites, 22 in the United States and 36 in Asia.

Ninety-nine patients are currently being screened for potential enrollment in the study. We estimate that 30% to 50% of the patients in screening should be eligible for study enrollment.

In addition to sites in Asia and the U.S., sites are being added in Europe, Mexico and possibly South America, to bring the total number of sites to approximately 100. These sites are targeted to enroll patients before the end of 2006.

"We are aggressively moving forward to open new sites and enroll patients, and I am pleased that in only six weeks, we already have 99 patients in screening," said Deirdre Y. Gillespie, M.D., President and CEO of La Jolla Pharmaceutical Company. "We now plan to add at least 20 additional sites beyond the initial 100 to further accelerate and strengthen enrollment in the trial. We expect to begin activating these additional sites before the end of the year. Our target for completing patient recruitment is the second half of 2007."

This Phase 3 study is planned to enroll approximately 600 patients, and most of these patients will be treated with higher doses than in previous studies. This trial will assess a 300 mg per week and a 900 mg per week dose, as well as the 100 mg per week dose used in the prior Phase 3 trial. Of the 600 patients, two-thirds will be treated with Riquent, and the majority of the Riquent-treated patients will receive one of the two higher doses.

La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people around the world. The Company's leading product in development is Riquent®, which is designed to treat lupus renal disease, a leading cause of sickness and death in patients with lupus. The Company is also developing small molecules to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The NASDAQ Global Market under the symbol LJPC.
posted by pharma-insight @ 8:53 AM  
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