SUNNYVALE, Calif., Feb. 7 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that the company has initiated a Phase Ib, double-blind,
placebo-controlled, multiple oral dose study of SCIO-469, its proprietary oral
p38 kinase inhibitor for the treatment of Rheumatoid Arthritis (RA). The
purpose of the study is to determine the safety, tolerability and
pharmacokinetics of multiple oral doses of SCIO-469. The Phase Ib trial will
enroll 20 healthy volunteers who will each be dosed multiple times over a
two-week period. Scios expects to announce the results of this trial in the
second quarter of 2001.
"This trial follows our recently completed Phase Ia dose-ranging study in
which volunteers received single doses of SCIO-469," said George Schreiner,
M.D., Ph.D., Scios' chief scientific officer. "In addition to establishing
the safety and tolerability of our compound over a longer period of time, the
pharmacokinetic information obtained in this trial will help us establish the
optimal dose and regimen for the Phase II trial that we plan to begin in the
fourth quarter of this year."
Scios recently completed a Phase Ia trial of SCIO-469 in which single oral
doses were shown to be safe and well tolerated. The Phase Ia trial enrolled
30 volunteers.
"The extremely rapid pace with which SCIO-469 is progressing through
clinical trials is a result of the focused approach of Scios' development
team," said Patricia A. Baldwin, Ph.D., vice president of quality and product
development. "The clinical data thus far confirm SCIO-469 is a potent and
highly selective inhibitor of p38 kinase. We are on an aggressive timeline
with this priority development project and believe this will emerge as an
important addition to our growing pipeline."
SCIO-469 is the first product to come from Scios' novel approach to drug
discovery. p38 kinase is an intracellular signaling enzyme that is activated
by environmental stress or ischemia. p38 kinase stimulates TNF (tumor
necrosis factor) production and COX-2 (cyclooxygenase-2) biosynthesis, leading
to inflammation. Recent advances in the treatment of RA have been made by
antagonizing TNF, markedly relieving the symptoms and retarding the
progression of the disease. These treatments are currently administered via
injection or infusion. SCIO-469 is an oral treatment, offering a more
convenient and tolerable treatment for patients.
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.
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. 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 RA 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, 1999 and subsequent reports on form 10-Q.
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.
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