Lupus Medical Journal Highlights La Jolla Pharmaceutical's Lead Drug Candidate
In a scientific paper entitled "Pre-Treatment Affinity for LJP 394 Influences Pharmacodynamic Response in Lupus Patients," McNeeley et al. discuss research conducted by Company scientists demonstrating that, following four months of weekly treatment with LJP 394, there was a dose-dependent reduction in the affinity of a patient's antibodies for LJP 394. The authors state, "The purpose of this study was to determine if the affinity of anti-dsDNA antibodies from SLE patients for LJP 394 would predict the pharmacodynamic response of these patients to therapy....Patients with the highest initial affinity for LJP 394 had both the largest percentage change in affinity and greatest decrease in anti-dsDNA titers over the duration of the trial....The data from our lab indicates that LJP 394 can immunodeplete the majority of anti-dsDNA activity from a range of lupus patients."
These results, based on Phase II clinical trial data, supported the use of an affinity assay in determining which patients would potentially respond to drug treatment. In the Phase II/III trial, high-affinity drug-treated patients identified using the affinity assay (89% of patients) had one-third as many renal flares and received less than one-half as many treatments with high-dose corticosteroids and/or cyclophosphamide compared to high-affinity placebo-treated patients.
LJP 394 is designed to arrest the production of antibodies to dsDNA in lupus patients and to arrest or delay lupus renal disease without suppressing the healthy functions of the immune system. In lupus, antibodies to double-stranded DNA (dsDNA) are believed to be responsible for kidney disease, a leading cause of morbidity and mortality in lupus.
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases such as lupus, which afflict several million people in the United States and Europe. The Company is conducting a Phase III trial of LJP 394 in patients with lupus kidney disease, a leading cause of sickness and death in these patients. The Company is also developing drugs for antibody-mediated stroke, heart attack, and deep-vein thrombosis, and for other antibody-mediated diseases. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit our Web site: http://www.ljpc.com.
Except for historical statements, this press release contains forward-looking statements, including, without limitation, statements regarding the analysis of results from pre-clinical 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 pre-clinical or other prior trials and pre-IND studies of the LJP 1082 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 or termination of development by the Company would result in delays or lack of government approval to market the compounds. 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 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, 2000.
Source: La Jolla Pharmaceutical Company