Phase II/III clinical trial of its clinical candidate for lupus, LJP 394, at the World Congress of Nephrology

[Guest guest]

SAN FRANCISCO, Oct. 16 /PRNewswire/ -- La Jolla Pharmaceutical Company presented

additional data from

an earlier Phase II/III clinical

trial of its clinical candidate for lupus, LJP 394, at the World

Congress

of Nephrology. This international medical meeting, hosted by the

American Society of Nephrology and the

International Society of Nephrology, is expected to attract 14,000 health-care

professionals.

Data from the trial involving more than 200 patients

were presented on the severity of patients' renal disease. Like lupus

nephritis patients in the general population, a majority of the

patients

enrolled in the study had severe or moderate renal disease. In

patients

with renal biopsies, 70% had World Health Organization Classifications

III (focal) or IV (diffuse) proliferative glomerulonephritis.

Data presented on outcomes following a renal flare in

all patients and in patients with impaired renal function demonstrated

the importance of preventing renal flares. In all patients, a renal

flare was declared only when a predefined, significant reproducible

increase in serum creatinine, proteinuria, or hematuria was observed.

Eighty-three percent of patients who had a renal flare required

treatment

with high-dose corticosteroids and/or cyclophosphamide and 48%

required

hospitalization. In patients who entered the trial with impaired renal

function and who flared, serum creatinine levels worsened

significantly

and increased from an average of 1.9 mg/dL at baseline to 5.0 mg/dL

at final visit. In lupus patients, renal flares can lead to a loss of

kidney function, kidney failure, and the need for long-term dialysis.

Most importantly, as previously reported, in the high-affinity group

(89% of patients), there were one-third the number of renal flares in

drug- treated patients when compared with placebo-treated patients

(p<0.008).

There were also fewer than half as many treatments with high-dose

corticosteroids

and/or cyclophosphamide in the drug-treated group compared with the

placebo- treated group (p<0.001). In the 21 high affinity patients

with

impaired renal function, there were no renal flares (0%) in the 11

drug-treated

patients, while there were six renal flares (60%) in the 10

placebo-treated

patients (p = 0.004). Patients with impaired renal function had a

serum

creatinine level of 1.5 mg/dL or greater at baseline. The Phase II/III

study was stopped prior to completion. The Company is currently

conducting

a Phase III clinical trial to confirm the positive results of the

Phase

II/III clinical trial.

A. Tumlin, M.D., Associate Professor of Medicine

at Emory University in Atlanta, presented " The B-Cell Toleragen® LJP

394 reduces renal flares in patients with lupus nephritis: A

prospective

double-blinded, placebo- controlled trial, " which was coauthored by

Gerald B. Appel, M.D., Director of Clinical Nephrology at Columbia

Presbyterian

Medical Center in New York, and D. Linnik, Ph.D., Executive

Vice President of Research at La Jolla Pharmaceutical Company.

" LJP 394 reduced antibodies to double-stranded DNA, recurrent

lupus nephritis and the need for immunosuppressive drug treatment in

patients with high-affinity antibodies to the drug, " commented Dr.

Tumlin.

" LJP 394 has the potential to treat patients with serious lupus

nephritis

who are at a higher risk of progressing to end-stage renal disease and

dialysis. "

LJP 394 is designed to arrest the production of antibodies

to double- stranded DNA (dsDNA) in lupus patients and to arrest or

delay

lupus renal disease without suppressing the healthy functions of the

immune system. In lupus, antibodies to dsDNA are believed to be

responsible

for kidney disease, a leading cause of morbidity and mortality in

lupus.

La Jolla Pharmaceutical Company is a biotechnology company

leading the development of therapeutics for antibody-mediated

autoimmune

diseases afflicting several million people in the United States and

Europe. The Company is conducting a Phase III trial of LJP 394 in

patients

with lupus kidney disease, a leading cause of sickness and death in

these patients. The Company filed an IND in August 2001 for its second

drug candidate, LJP 1082, for the treatment of antibody-mediated

thrombosis.

The Company's common stock is traded on The Nasdaq Stock Market under

the symbol LJPC. For more information about the Company, visit our Web

site: http://www.ljpc.com/.

Patients interested in the Phase III lupus trial can call

1-888-30-LUPUS

for information.

Except for historical statements, this press release contains

forward- looking statements, including, without limitation, statements

regarding the analysis of results from pre-clinical and clinical

studies

as well as La Jolla Pharmaceutical's drug candidates and drug

development

plans. These forward- looking statements involve risks and

uncertainties,

and a number of factors, both foreseen and unforeseen, could cause

actual

results to differ materially from those anticipated. Clinical results

for LJP 394 are derived from a trial that was terminated prior to

completion,

and certain data are incomplete. The Company's blood test to measure

binding affinity for LJP 394 is experimental and has not been

validated

by independent laboratories. Tolerance, or the specific inactivation

of pathogenic B cells, is a new technology that has not been proven.

The Company's ability to develop and sell its products in the future

may be affected by the intellectual property rights of third parties.

Future clinical trials of the Company's drug candidates may have

negative

or inconclusive results. Future clinical trials of the Company's drug

candidates may not support results of pre-clinical or other prior

trials

and clinical trials of LJP 394 for treating lupus or LJP 1082 for

treating

antibody- mediated thrombosis may reveal a potential safety issue

requiring

the development of a new candidate. Any delays in testing of the

Company's

drug candidates or termination of development by the Company would

result

in delays or lack of government approval to market the compounds. The

development of drug candidates involves many risks and uncertainties,

including, without limitation, whether the drug can provide a

meaningful

clinical benefit, and any positive results observed to date may not be

indicative of future results. La Jolla

Pharmaceutical's other potential

drug candidates involve comparable risks. Interested parties are urged

to review the risks detailed from time to time in La Jolla

Pharmaceutical

Company's Securities and Exchange Commission filings, including the

report on Form 10-K for the year ended December 31, 2000.

http://www.uklupus.co.uk/news119.html