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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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LA JOLLA PHARMACEUTICALS' LJP 394 REDUCES RENAL FLARE IN LUPUS PATIENTSDate: 31 Oct 2000 CommentsLJP 394 Reduces Renal Flares in Lupus Patients with Poor Renal Function;Three Papers Presented at American College of Rheumatology Meeting
PHILADELPHIA, Oct. 31 - La Jolla Pharmaceutical Company (Nasdaq: LJPC) said that in a group of 27 lupus patients with poor renal function, its experimental drug LJP 394 prevented renal flares completely in the 11 LJP 394-treated patients with high-affinity antibodies to the drug. Renal flares are life-threatening episodes of disease activity during which kidney tissue is destroyed and kidney failure can occur. The findings from a Phase ll/lll trial of LJP 394 were presented today at the 64th Meeting of the American College of Rheumatology (ACR) in a presentation entitled "Effect of LJP 394 on Patients with Greatest Impairment of Renal Function at Baseline in the 90-05 Trial." In the Phase II/III study, more than 200 patients were enrolled and treated for up to 18 months. Renal flares reduced in patients with poor renal function In a predefined group of 27 patients with poor renal function, there were six renal flares in 11 patients treated with placebo (55%) versus 3 renal flares in 16 patients (19%) treated with LJP 394 (p = 0.097), a reduction of more than 50%. None of the patients with high-affinity antibodies to LJP 394 who were treated with drug had a renal flare. In the group of 22 patients with poor renal function and with high-affinity antibodies to LJP 394, there were six renal flares in 11 patients treated with placebo (55%), but no flares in 11 patients (0%) treated with drug (p = 0.012). Patients with poor renal function were defined as those who entered the trial with serum creatinine levels of 1.5 mg/dL or greater. A serum creatinine level of 1.5 mg/dL or greater indicates that a lupus patient has lost about 50 percent of kidney function and is more likely to progress to end-stage renal disease. "Today's results suggest that treatment with LJP 394 may provide potential benefit to those patients with serious lupus renal disease who are at the greatest risk of progressing to end-stage renal disease and dialysis," said James Tumlin, M.D., Associate Professor of Medicine, Renal Division, Emory University School of Medicine. "If confirmed in the ongoing Phase III trial, these results for LJP 394 may represent a whole new paradigm in the treatment of complicated lupus nephritis." Renal flares reduced in patients with high-affinity antibodies to LJP 394 A second presentation was given by Donato Alarcon-Segovia, M.D., Professor of Medicine, Rheumatology, Universidad Nacional Autonoma de Mexico, General Director of Instituto Nacional de la Nutricion in Mexico City and a leading lupus clinical researcher. His talk, entitled "SLE Trial Shows Fewer Flares in LJP 394-Treated Patients with High-Affinity Antibodies to LJP 394: 90-05 Trial Results," was given as a platform presentation in a session on Novel Therapeutic Agents for SLE. In the Phase II/III trial, 89% of the patients had high-affinity antibodies to LJP 394. In patients with high-affinity antibodies to LJP 394, time to renal flare, the primary endpoint of the trial, was significantly increased in the drug-treated population when compared to the placebo-treated group (p = 0.008). In the high-affinity group, there were one-third as many renal flares in LJP 394-treated patients (7) compared to placebo-treated patients (21) (p = 0.007). Furthermore, in the high-affinity group, there were less than one-half as many treatments with high-dose corticosteroids and/or cyclophosphamide in drug-treated patients (13) compared to placebo-treated patients (34) (p < 0.001). The drug appears to be well tolerated. There were no significant differences in serious adverse events between the drug-treated and placebo-treated groups in the Phase II/III trial. "Renal disease is a leading cause of morbidity and mortality in lupus patients," said Dr. Alarcon-Segovia. "There are no drugs approved for the prevention of lupus renal flares. LJP 394 is designed to reduce these potentially life-threatening events and could have a major impact on lupus renal disease." In lupus patients, renal flares lead to a loss of kidney function, kidney failure, and the need for long-term dialysis. In the U.S., lupus patients on dialysis incur annual costs in excess of $40,000. Current therapies -- high doses of corticosteroids and chemotherapy drugs -- have increased 10-year patient survival, but the toxic effects of these drugs have made them a major cause of morbidity and mortality in lupus. Of the one million lupus patients in the U.S. and Europe, it is estimated that about 50% have kidney disease. LJP 394 treatment reduces antibody affinity to LJP 394 A third paper, entitled "Affinity of Antibodies for LJP 394 Influences Pharmacodynamic Response to LJP 394 in SLE Patients with Positive dsDNA Antibody Titers," reported that LJP 394 treatment reduces a patient's antibody affinity. In the Phase II/III trial, when patients with high-affinity antibodies to drug were treated with 100 mg per week of LJP 394 for four months, their average affinity for drug was reduced by about 60%, whereas the affinity of placebo-treated patients' antibodies was essentially unchanged (p < 0.001). This reduction in antibody affinity following drug treatment indicates the elimination of high-affinity antibodies from a patient's circulation and is consistent with the induction of immune tolerance in those B cells producing high-affinity antibodies. The ability of LJP 394 to specifically reduce antibody affinities has been shown in two trials, the Phase II/III trial and a previous Phase II study. Background The Company recently announced that it has initiated a Phase III trial for LJP 394. This study of several hundred lupus patients is designed to confirm the ability of LJP 394 to treat lupus kidney disease. La Jolla Pharmaceutical plans to conduct this double-blind, placebo-controlled trial at more than 50 major medical centers in North America and Europe. La Jolla Pharmaceutical's drug candidates, known as Toleragens(R) are designed to arrest the production of disease-causing antibodies without suppressing the healthy functions of the immune system. Its Tolerance Technology(R) platform has been shown to reduce targeted disease-causing antibodies in five human clinical trials in lupus patients. La Jolla Pharmaceutical Company (LJP) is a San Diego-based biotechnology company developing therapeutics for antibody-mediated diseases, such as lupus and stroke, which afflict several million people in the United States and Europe. The Company is also developing drugs for antibody-mediated stroke, heart attack and deep-vein thrombosis, for xenotransplantation, and for other antibody-mediated diseases. The Company's common stock trades on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit our web site: www.ljpc.com. DISCLAIMER Except for historical statements, this press release contains forward-looking statements, including without limitation statements regarding the analysis of results from preclinical and clinical studies as well as La Jolla Pharmaceutical's drug candidates and drug development plans. These forward-looking statements involve risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from those anticipated. Clinical results for LJP 394 are derived from a trial that was terminated prior to completion, and certain data are incomplete. The Company's blood test to measure binding affinity for LJP 394 is experimental and has not been validated by independent laboratories. Tolerance, or the specific inactivation of pathogenic B cells, is a new technology that has not been proven. The Company's ability to develop and sell its products in the future may be affected by the intellectual property rights of third parties. Future clinical trials of the Company's drug candidates may have negative or inconclusive results. Future clinical trials of the Company's drug candidates may not support results of preclinical or other prior trials and pre IND studies of the Company's new candidate for treating antibody-mediated thrombosis may reveal a potential safety issue requiring the development of a new candidate. Any delays in testing of the Company's drug candidates and/or termination of development by the Company would result in delays or lack of government approval to market the compound. The development of drug candidates involves many risks and uncertainties, including, without limitation, whether the drug can provide a meaningful clinical benefit, and any positive results observed to date may not be indicative of future results. La Jolla Pharmaceutical's other potential drug candidates, including its Toleragen candidate for xenotransplantation, which has not progressed to clinical trials, involve comparable risks. Interested parties are urged to review the risks detailed from time to time in La Jolla Pharmaceutical Company's Securities and Exchange Commission (SEC) filings, including the report on Form 10-K for the year ended December 31, 1999 and in Form 10-Q for the quarter ended June 30, 2000.
PROHOST COMMENTS Seious and excellent news. Very serious and important news.
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