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SAN DIEGO, March 11 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical
Company (Nasdaq: LJPC) today announced additional data from its
Phase 3 and
Phase 2/3 clinical trials of Riquent(R) (abetimus sodium) which
showed that
after one year of treatment, the number of lupus patients with a
reduction in
proteinuria of at least 50% from baseline was greater in the Riquent-treated
group than in the placebo-treated group. Proteinuria, or protein
in the
urine, results from ongoing kidney inflammation. The reduction of
proteinuria
is one of the goals for the treatment of lupus patients with renal
disease.
Monitoring the level of a patient's proteinuria is a routine and
important way
to help determine the severity of renal disease. These data were
included in
the Company's New Drug Application for Riquent that is currently
being
reviewed by the United States Food and Drug Administration.
Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical, will
present
these results today at 10:15 a.m. and 11:15 a.m. Eastern Time during
the
SG Cowen 24th Annual Healthcare Conference. The conference is taking
place
March 8-11, 2004 at the Marriott Copley Place in Boston, MA. An
audio webcast
of the presentation will be available through the Company's website
at
http://www.ljpc.com .
"The reductions in proteinuria we observed in patients treated
with
Riquent are encouraging because a marked increase in proteinuria
often
corresponds to more severe kidney inflammation and is an indication
of the
need for additional treatment," said Kenneth R. Heilbrunn,
M.D., Vice
President of Clinical Development.
In patients who had 24-hour urine protein measured at both baseline
and at
week 52 during the Phase 3 trial, 41% (26/63) of patients in the
Riquent-
treated group with high-affinity antibodies to Riquent achieved
a 50% or
greater reduction from baseline in the amount of protein in their
urine at
week 52, compared with 28% (23/81) of patients in the placebo-treated
group
with high-affinity antibodies (nominal p = 0.047). In patients who
had
24-hour urine protein measured at both baseline and at approximately
week 52
during the Phase 2/3 trial, 44% (23/52) of patients in the Riquent-treated
group with high-affinity antibodies had a 50% or greater reduction
from
baseline in the amount of protein in their urine at approximately
week 52,
compared with 18% (11/61) of patients in the placebo-treated group
with
high-affinity antibodies (nominal p = 0.002). The measurement of
24-hour
urine protein was specified in each protocol at defined time points,
but the
analysis of the reduction in proteinuria was conducted on a retrospective
basis.
About Lupus and Riquent
Lupus (systemic lupus erythematosus or SLE) is a chronic, life-threatening
autoimmune disease. About 90% of lupus patients are female, and
many develop
the disease during their childbearing years. Approximately 50% of
lupus
patients have renal disease, which can lead to irreversible kidney
damage,
kidney failure and the need for dialysis. Latinos, African Americans
and
Asians face an increased risk of serious renal disease associated
with lupus.
Riquent is designed to reduce levels of antibodies to double-stranded
DNA
(dsDNA) that are believed to be responsible for lupus renal disease,
a leading
cause of morbidity and mortality in lupus patients. The current
standard of
care for lupus renal disease often involves treatment with high
doses of
corticosteroids and immunosuppressive drugs that can cause severe
side effects
including diabetes, hypertension and sterility, and may leave patients
vulnerable to opportunistic infections.
La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases and inflammation
afflicting several million people in the United States and Europe.
The
Company is developing Riquent(R), formerly known as LJP 394, for
the treatment
of lupus kidney disease, a leading cause of sickness and death in
patients
with lupus. The Company is also developing LJP 1082 for the treatment
of
antibody-mediated thrombosis, a condition in which patients suffer
from
recurrent stroke, deep-vein thrombosis and other thrombotic events,
and is in
the early stage of developing small molecules to treat various other
autoimmune and inflammatory conditions. The Company's common stock
is traded
on The Nasdaq Stock Market under the symbol LJPC. For more information
about
the Company, visit its website: http://www.ljpc.com .
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