La Jolla PharmaceUtical Files IND to begin clinical testing of drug
Candidate for Antibody-Mediated stroke and deep-vein thrombosis
SAN DIEGO -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) recently announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase I/II clinical trial of LJP 1082, its clinical candidate for the treatment of antibody-mediated thrombosis, a life-threatening blood-clotting disorder. The normal regulatory review has been completed, and the Company is preparing to begin the clinical study.
"The successful filing of an IND for our second clinical candidate represents a major milestone for the Company. We now have two clinical candidates based on our proprietary Tolerance Technology(R) approach," said Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical Company. "Like our Phase III drug candidate for lupus, LJP 1082 is designed to reduce the production of disease-causing antibodies without affecting the disease-fighting ability of the immune system. LJP 1082 represents the first specific therapy to focus on the cause of this disease."
LJP has presented positive pre-clinical results demonstrating that LJP 1082 reduces disease-causing antibodies and the related B cells in several animal models. These studies also confirmed the impact of the targeted autoantibodies on a key clot-promoting coagulation factor, Factor Va. These results were presented at the 26th International Stroke Conference and at the 9th International Symposium on Antiphospholipid Antibodies. Additional data on LJP 1082 were presented at the18th International Society of Thrombosis and Haemostasis and published in Proceedings of the National Academy of Sciences and Thrombosis and Haemostasis.
Antibody-mediated thrombosis, also known as Antiphospholipid Syndrome (APS), is an autoimmune disease afflicting more than two million patients, including many lupus patients, in the United States and Europe. These patients face an increased risk of blood clots that can result in stroke, heart attack, deep-vein thrombosis, recurrent fetal loss and post-operative complications following cardiovascular surgery.
Many patients in their 20's and 30's are at risk of suffering recurrent thrombotic events at more than double the rate of individuals without the disease-causing antibodies. Current therapy relies on anticoagulants, which are difficult to manage and cause serious side effects such as an increased risk of life-threatening bleeding episodes.
La Jolla Pharmaceutical Company is a biotechnology company that is leading the development of 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 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 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.