SUNNYVALE, Calif., Feb. 27 /PRNewswire-FirstCall/ --
Scios Inc. (Nasdaq: SCIO) announced today that enrollment has begun in a
Phase IIa clinical trial evaluating SCIO-469, its novel oral p38 kinase
inhibitor for the treatment of rheumatoid arthritis (RA).
"This marks a major milestone for the company as we advance another
promising compound from our pipeline into further clinical development," said
Darlene P. Horton, M.D., Scios' Vice President of Medical Affairs. "SCIO-469
could become a valuable new oral treatment for the millions of RA patients
affected by this disease worldwide."
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 from this study in the first quarter of 2003.
About SCIO-469
SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a
stimulatory modulator of pro-inflammatory factors including tumor necrosis
factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (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 studies demonstrated that doses in the ranges tested were well
tolerated in healthy volunteers. Due to the physiology of inhibiting
p38 kinase, these doses also may have benefits related to the inhibition of
IL-1 and COX-2.
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 would be the first mechanism-specific oral product aimed at reducing
TNF-alpha.
About Rheumatoid Arthritis
RA 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.
About 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 "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, 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.
SOURCE Scios, Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Investors, David Gryska of Scios, Inc.,
+1-408-616-8303; or Media, Jim Weiss, +1-415-389-5055, or Sara
Moorin, or +1-212-867-1773, both for Scios, Inc.
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