La Jolla Pharmaceutical Company Announces FDA Acceptance of IND for LJPC-501
Published: Jul 02, 2013
SAN DIEGO, CA--(Marketwired - July 02, 2013) - La Jolla Pharmaceutical Company (OTCBB: LJPC) ("La Jolla" and "Company"), announced today that the FDA Division of Cardiovascular and Renal Products has accepted the Company's Investigational New Drug ("IND") application for LJPC-501. La Jolla will start a Phase 1 clinical trial of LJPC-501 in patients with hepatorenal syndrome ("HRS"), Type 1 and Type 2.
"We are excited to bring a second compound into the clinic this year, especially for a disease such as HRS, in which no approved therapies are available," said George Tidmarsh, MD, PhD, President and CEO of La Jolla. "La Jolla is committed to providing therapies for patients with life-threatening diseases, and the approval of our IND for LJPC-501 is an important step in the process toward meeting this goal."
La Jolla plans to initiate a Phase 1 trial in HRS in the third quarter. For additional information on this study, please visit www.ljpc.com.
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 systemc 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. The Company has filed a patent covering LJPC-501 in renal failure and believes that Type 1 HRS may be an orphan disease amenable to orphan designation from FDA.
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. 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.
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264
Chester S. Zygmont, III
Director of Finance
La Jolla Pharmaceutical Company
Phone: (858) 207-4262
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