SAN DIEGO, CA, USA I July 2, 2013 I 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 systemic blood pressure, the kidneys induce both sodium and water retention, which contribute to ascites, a major complication associated with HRS.
About LJPC-501
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.
SOURCE: La Jolla Pharmaceutical Co
Post Views: 181
SAN DIEGO, CA, USA I July 2, 2013 I 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 systemic blood pressure, the kidneys induce both sodium and water retention, which contribute to ascites, a major complication associated with HRS.
About LJPC-501
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.
SOURCE: La Jolla Pharmaceutical Co
Post Views: 181
