- Preclinical Studies Show Scios Compounds Reduce Clinical Severity and
Progression of Collagen-Induced Arthritis -
NEW ORLEANS, Oct. 28 /PRNewswire-FirstCall/ -- Scios Inc. (Nasdaq: SCIO),
today announced that preclinical study results indicate that SCIO-469, the
company's first-generation oral p38 MAP kinase inhibitor, and SCIO-323, a
second-generation p38 MAP kinase inhibitor, reduce clinical severity and
radiographic progression of experimental collagen-induced arthritis. Data
from these studies will be presented here today during an oral podium session
on emerging new treatments for arthritis at the 66th Annual American College
of Rheumatology (ACR) Scientific Meeting.
"These studies indicate that inhibition of p38-alpha MAP kinase results in
anti-inflammatory effects in both acute and chronic models of inflammation,
and leads to improved clinical outcomes in animal models," said Ernest Brahn,
M.D., Professor of Medicine, Division of Rheumatology, UCLA School of
Medicine, Los Angeles, who will present the data. "Since selective inhibitors
of TNF-alpha, IL-1-beta, and COX-2 are currently being used as individual
agents to treat rheumatoid arthritis, a novel oral p38-alpha MAP kinase
inhibitor, such as SCIO-469, that targets all three is an ideal candidate for
expanded research in human clinical trials."
Study Details
The presentation, "Inhibition of Collagen-Induced Arthritis with an
Inhibitor of P38 MAP Kinase," will be presented today at 3:30 p.m. CST in room
343-345 at the New Orleans Convention Center. The abstract (ACR presentation
#1520) is available online at http://www.rheumatology.org/.
P38-alpha mitogen-activated protein (MAP) kinase has been shown to
modulate the activity of key pro-inflammatory pathways including tumor
necrosis factor-alpha (TNF-alpha), interleukin-1-beta (IL-1-beta) and
cyclooxygenase-2 (COX-2).
In the preclinical studies reported here, SCIO-469 was shown in vitro
using human blood cells to block the production of TNF-alpha, IL-1-beta, and
COX-2 mRNA in a dose-related manner in response to an inflammatory stimulus.
In an autoimmune model of rheumatoid arthritis, rats with existing disease
were randomized to receive once a day oral doses of SCIO-469 or vehicle.
There was a dose-related reduction in the severity of arthritis (joint
swelling and erythema) that in the high dose group was observed 48 hours after
initiation of treatment and continued through the course of the 28-day study
(p<0.05). Blinded radiographic analysis of diseased joints on day 28 indicated
cessation of disease progression (p<0.01). None of the radiographs in the
high-dose treatment group demonstrated any evidence of bone erosion. A second
generation p38-alpha inhibitor, SCIO-323, was tested in this model and the
results confirmed the SCIO-469 findings with marked reductions in clinical
severity scores (p<0.01) and blinded radiographic scores (p<0.001) compared to
the control group.
About SCIO-469
SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a
stimulatory modulator of pro-inflammatory factors including TNF-alpha,
IL-1-beta and COX-2, all of which are known to contribute to both symptoms and
disease progression in patients with RA. Preclinical data demonstrated that
oral SCIO-469 leads to suppression of induced TNF-alpha levels over a wide
range of doses. Two Phase I trials demonstrated that doses in the ranges
tested were well tolerated in healthy volunteers.
Scios is currently enrolling patients in a Phase IIa trial of SCIO-469.
This multi-center, randomized, placebo-controlled clinical study will enroll
120 patients who have active RA and are receiving methotrexate. The main
objective of the study is to evaluate the safety and tolerability of six
escalating doses of SCIO-469 in RA patients. The company expects to announce
results in the first quarter of 2003.
Existing protein-based products that antagonize TNF-alpha are prescription
products administered only through injection or infusion, and they represent a
multi-billion dollar annual market in the United States. If approved,
SCIO-469 could become the first mechanism-specific oral product aimed at
reducing TNF-alpha and other cytokines.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressively worsening autoimmune disease of
unknown origin in which the body's natural immune system attacks healthy joint
tissue causing inflammation and joint damage. RA is a systemic disease that
affects the entire body and is one of the most common forms of arthritis. It
is characterized by inflammation of the membrane lining the joint, which
causes pain, stiffness, warmth, redness and swelling. The inflamed joint
lining, the synovium, can invade and damage bone and cartilage. The involved
joint can lose its shape and alignment, resulting in pain and loss of
movement. According to the Arthritis Foundation, rheumatoid arthritis affects
2.1 million Americans.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for
cardiovascular and inflammatory disease. The Company's disease-based
technology platform integrates expertise in protein biology with computational
and medicinal chemistry to identify novel targets and rationally design small
molecule compounds for large markets with unmet medical needs.
Forward-Looking Safe Harbor Statement
This news release contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. We generally identify such forward-looking statements
using words like "estimate," "believe," "intend," "expect," "may," "should,"
"plan," "project," "contemplate," "anticipate" or similar statements.
Statements that are not historical facts are forward-looking statements based
on current assumptions that involve risks and uncertainties. These risks and
uncertainties may include the sales penetration and success of Natrecor, the
success of clinical trials of Natrecor and our pipeline products, including
SCIO-469 and inhibitors to TGF-beta, our ability to partner the development
and commercialization of our pipeline products and Natrecor (outside the U.S.
and Europe) with third parties on favorable terms, or at all, as well as other
risks detailed from time to time in the reports filed by Scios with the SEC,
including the Company's quarterly reports and annual report on Form 10-K.
Actual results, performance or achievements of Scios may differ significantly
from those described in these forward-looking statements. Scios disclaims any
intention or obligation to update or revise any financial projections or
forward-looking statements, whether as a result of new information, future
events or otherwise.
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Related links:
http://www.sciosinc.com
CONTACT:
Media and Investors - Suzanne Beveridge of
Scios Inc., +1-408-616-2947, or Media - Jim Weiss of WeissCom
Partners, Inc., +1-415-260-1274, or Investors - Fern Lazar or
Sara Moorin, +1-212-867-1762, both of Lazar Partners Ltd.
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