Phase Ib Trial With Novel Compound for Rheumatoid Arthritis Scheduled to Begin
This Quarter
SUNNYVALE, Calif., Jan. 24 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that data from a recently completed Phase I clinical trial of
SCIO-469, Scios' novel oral p38 kinase inhibitor, indicate that the drug is
well-tolerated in healthy volunteers. Based on these results, Scios will
begin a Phase Ib multi-dose trial in healthy volunteers this quarter.
Scios is initially developing SCIO-469 as a treatment for Rheumatoid
Arthritis. 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.
"In its first clinical trial, SCIO-469 met our expectations," said
George Schreiner, M.D., Ph.D., chief scientific officer of Scios Inc.
"SCIO-469 demonstrated excellent oral bioavailability and plasma
pharmacokinetics. It was well-tolerated at a wide range of doses. We will
evaluate SCIO-469 in additional safety and efficacy studies this year to
further validate its potential for treating the millions of people who suffer
from RA worldwide."
The objective of this Phase I, placebo-controlled, single dose trial was
to evaluate the safety, tolerability and pharmacokinetic profile of six
different doses of SCIO-469 in healthy volunteers. No significant adverse
events were observed. In doses significantly greater than the anticipated
therapeutic dose range, some patients experienced mild, transient side
effects.
Preclinical data demonstrate that SCIO-469 inhibits p38 kinase, a
stimulatory modulator of pro-inflammatory factors including tumor necrosis
factor-alpha (TNFa), 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 TNFa 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.
"SCIO-469 is the first product from our new technology platform that
combines the Company's traditional strengths in molecular biology with
computational and medicinal chemistry," said Richard B. Brewer, Scios'
president and chief executive officer. "This expanded platform will enable
Scios to introduce novel therapeutics for cardiovascular and chronic
inflammatory diseases in a more aggressive timeframe than ever before. We
plan to bring another new development candidate into our pipeline in 2001."
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 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.; or Michelle
Choi of Edelman Public Relations, 212-704-4580, for Scios Inc.
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