SAN DIEGO, CA--(Marketwired - June 04, 2013) - La Jolla Pharmaceutical Company (OTCQB: LJPC) ("La Jolla" and "Company") announced today that is has submitted its investigational new drug ("IND") application to the FDA Division of Cardiovascular and Renal Products for LJPC-501. This IND is for the treatment of patients with Type 1 and Type 2 hepatorenal syndrome ("HRS"). HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure.
HRS is categorized into two types based on the rapidity of the progression of renal failure as measured by serum creatinine. Type 1 HRS is the more rapidly progressing type and is characterized by a 100% increase in serum creatinine to >2.5 mg/dL within two weeks. Less than 10% survive hospitalization, and the median survival is only a few weeks. Type 2 HRS is slower progressing, with serum creatinine rising gradually; however, these patients can develop sudden renal failure and become diagnosed with Type 1 HRS. Type 2 HRS patients survive four to six months on average.
"Submission of the IND for LJPC-501 demonstrates our commitment to developing a strong pipeline for the future of La Jolla," said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We hope LJPC-501 will benefit patients with HRS, especially given that there are no approved therapies for this fatal disease."
Initiation of a Phase 1 trial is expected later this year. The clinical study cannot begin before the IND is accepted by FDA.
About Hepatorenal Syndrome
HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis. In these patients, the diseased liver secretes vasodilator substances (e.g., nitric oxide and prostaglandins) into the bloodstream that cause under-filling of blood vessels. This low blood pressure state causes a reduction in blood flow to the kidneys. As a means to restore systemic blood pressure, the kidneys induce both sodium and water retention, which contribute to ascites, a major complication associated with HRS.
LJPC-501 is a peptide agonist of the renin-angiotensin system that acts to help the kidneys balance body fluids and electrolytes. Studies suggest that LJPC-501 may improve renal function in patients with HRS.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company dedicated to the development of medical treatments that significantly improve outcomes in patients with life-threatening diseases. GCS-100, the Company's lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. LJPC-501 is a product candidate for the treatment of hepatorenal syndrome. For more information on the Company, please visit http://www.ljpc.com.
Forward-Looking Statement Safe Harbor
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the U.S. Securities and Exchange Commission ("SEC"), all of which are available free of charge on the SEC's web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the development of GCS-100 and LJPC-501, the success and timing of future preclinical and clinical studies of this compound, and potential indications for which GCS-100 and LJPC-501 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.