Phase II Trial With Company's Novel Rheumatoid Arthritis Compound Scheduled
To Begin in Second Half of Year
SUNNYVALE, Calif., April 30 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that data from a Phase Ib clinical trial indicate that
SCIO-469, the company's novel oral p38 kinase inhibitor, was well-tolerated in
healthy volunteers over a two week dosing period. Scios also announced that,
based on the results of the Phase Ib trial, a Phase II human clinical trial is
planned to begin later this year in Rheumatoid Arthritis (RA) patients.
The objective of the randomized, double-blind, placebo-controlled, Phase Ib
dose-ranging study was to evaluate the safety and tolerability of multiple
oral dosing regimens of SCIO-469 in healthy volunteers.
"We are making good progress with SCIO-469 and achieving results that meet
our expectations at this point," said George Schreiner, M.D., Ph.D., chief
scientific officer of Scios Inc., who presented the initial results of the
Phase Ib trial today in London at SMI's second annual conference, Advances in
Anti-Arthritic Agents. "As we observed in our previous Phase Ia study,
SCIO-469 demonstrates excellent oral bioavailability and plasma
pharmacokinetics and is well-tolerated at a wide range of doses. We will
continue to evaluate SCIO-469 in Phase II studies that will begin later this
year to further validate its potential for treating the millions of people who
suffer from RA worldwide."
Scios is developing SCIO-469 as a treatment for Rheumatoid Arthritis (RA).
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.
Preclinical data demonstrate that SCIO-469 inhibits 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. Existing protein-based products that antagonize
TNF-alpha have been shown to markedly relieve the symptoms and retard the
progression of RA. As an oral inhibitor of TNF, SCIO-469 would offer more
convenient dosing over the existing products that must be injected or infused
in a medical office. It also has the potential for additional benefits
associated with its inhibition of IL-1 and COX-2.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for heart
failure and rheumatoid arthritis. The company's disease-based technology
platform integrates expertise in protein biology with combinatorial and
medicinal chemistry to identify novel targets and rationally design
protein-based and small-molecule compounds to treat cardiovascular and
inflammatory diseases, two of the world's leading unmet medical needs.
Additional information about Scios is available at its web site located at
http://www.sciosinc.com and in the company's various filings with the Securities and
Exchange Commission.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. These include
uncertainties associated with the successful completion of additional studies
with p38 kinase inhibitor, and the results of competing companies attempting
to develop or improve other treatments for Rheumatoid Arthritis and other
inflammatory diseases, as well as other risks detailed from time to time in
the reports filed by Scios with the SEC, including the company's annual report
on form 10-K for the year ended December 31, 2000.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Wendy Carhart of Scios Inc., 408-616-8325, or
Jim Weiss of Weisscomm, 415-203-0328, for Scios Inc.; or Michelle
Choi of Edelman Public Relations, 212-704-4580, for Scios Inc.
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