Jolla Pharmaceutical Company (NASDAQ: LJPC), a leader in the
development of innovative therapies intended to significantly improve
outcomes in patients suffering from life-threatening diseases, today
announced that the first patient has been enrolled in the Phase 1/2
clinical trial of LJPC-501
for the treatment of 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.
"We are very grateful to the investigator, the patient and the patient's
family," said George Tidmarsh, M.D., Ph.D., La Jolla's President and
Chief Executive Officer. "We believe that LJPC-501, which helps the
kidneys balance body fluids and electrolytes, may improve kidney
function in patients with HRS. For many patients with HRS, reduced
kidney function is the major debilitating aspect of their illness."
The clinical trial is an open-label, multi-center study of LJPC-501 in
patients with type 1 and/or type 2 HRS.
The trial is designed to enroll up to 15 patients with type 1 or type 2
HRS. The primary endpoint is safety and tolerability. Secondary
endpoints include determining the maximum tolerated dose and the effects
of LJPC-501 on serum creatinine through 5 days of treatment. Patients
will receive LJPC-501 at titrated doses, with a starting range from 1 to
100 ng/kg/min, by continuous infusion on days 1 through 5. Dose
titrations will occur every 4 hours until a mean arterial pressure of
110 mmHg is reached, maximum urine output is achieved or a dose of 100
ng/kg/min is achieved. Dosing will then continue at such maximum dose
through day 5.
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, a proprietary formulation of angiotensin II, is a peptide
agonist of the renin-angiotensin system that acts to stabilize blood
pressure. La Jolla is developing LJPC-501 for the treatment of
catecholamine-resistant hypotension (CRH), which is an acute,
life-threatening condition in which blood pressure drops to dangerously
low levels and is poorly responsive to current treatments. LJPC-501 has
been shown to raise blood pressure in a randomized, placebo-controlled
clinical trial in CRH, as well as animal models of hypotension. La Jolla
plans to initiate a Phase 3 registration program with LJPC-501 in the
treatment of CRH as the result of a recent meeting with the U.S. Food
and Drug Administration (FDA) at which agreement was reached that blood
pressure could serve as an appropriate primary endpoint for approval.
Due to the estimated size of the patient population in the United States
for this indication, La Jolla has filed an application for Orphan Drug
status for LJPC-501. Studies have shown that LJPC-501 may also improve
renal function in patients with hepatorenal syndrome (HRS).
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused
on the discovery, development and commercialization of innovative
therapies intended to significantly improve outcomes in patients
suffering from life-threatening diseases. LJPC-501, La Jolla's lead
product candidate, is a proprietary formulation of angiotensin II for
the potential treatment of catecholamine-resistant hypotension and
hepatorenal syndrome. GCS-100, La Jolla's second product candidate, is a
first-in-class inhibitor of galectin-3 for the potential treatment of
chronic kidney disease. LJPC-1010, La Jolla's third product candidate,
is a more potent and purified derivative of GCS-100 that can be
delivered orally for the potential treatment of nonalcoholic
steatohepatitis. LJPC-401, La Jolla's fourth product candidate, is a
natural peptide for the potential treatment of iron overload. For more
information on La Jolla, 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 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
timing for the commencement of clinical studies and the anticipated
timing for completion of such studies; the success of future development
activities for LJPC-501, GCS-100, LJPC-1010 and LJPC-401; estimated
market sizes and the ability to successfully receive Orphan Drug
designation for LJPC-501; and potential indications for which LJPC-501,
GCS-100, LJPC-1010 and LJPC-401 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
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