SCIO-469 Advances to 5th of 6 Dosing Groups; SCIO-323 Moves into Clinic
SUNNYVALE, Calif., Jan. 6 /PRNewswire-FirstCall/ --
Scios Inc. (Nasdaq: SCIO) announced today that enrollment in its ongoing
Phase II clinical trial evaluating SCIO-469, its first-generation oral p38 MAP
kinase inhibitor, has advanced to the fifth out of six dosing groups in
patients with rheumatoid arthritis (RA) already receiving methotrexate.
Enrollment in this group began following the independent safety review of the
previous dosing groups, which have completed treatment and follow-up.
The Company also announced that it has begun a Phase I, double-blind,
placebo-controlled, dose escalation study of SCIO-323, its second-generation
oral p38 MAP kinase inhibitor. The purpose of the Phase I trial is to
determine the safety, tolerability and pharmacokinetics of oral doses of
SCIO-323 in healthy volunteers.
"As we near completion of our Phase II trial with SCIO-469 and advance the
next-generation of p38 MAP kinase inhibitors into the clinic, we are very
encouraged by the progress we are making overall with this comprehensive
program," said George Schreiner, M.D., Ph.D., Scios' chief scientific officer.
"This progress further validates Scios' proprietary and focused kinase
research and development program, which has the potential to produce the first
oral, specific inhibitors of tumor necrosis factor (TNF) and interleukin-1
(IL-1). These immune factors that have been shown to be major contributors to
the symptoms and tissue destruction of RA and other immune disorders such as
inflammatory bowel disease."
About Scios' p38 MAP Kinase Inhibitor Program
SCIO-469 and SCIO- 323 belong to a new class of treatments that inhibit
p38 MAP kinase, a stimulatory modulator of pro-inflammatory factors including
tumor necrosis factor-alpha (TNF-alpha), 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 and
SCIO-323 lead to suppression of induced TNF-alpha levels over a wide range of
doses.
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 and SCIO-323 would be one of the first mechanism-specific oral
products 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.
JP Morgan H&Q Webcast Details
Scios president and CEO Richard B. Brewer will be presenting a corporate
update today at the 21st JP Morgan Hambrecht & Quist Healthcare Conference at
8:00 a.m. PST in the St. Francis Hotel's Colonial Room in San Francisco. His
presentation will be webcast live, and can be accessed by logging onto the
investor relations section of Scios' website at http://www.sciosinc.com. To request
copies of press releases or other company reports, those interested can call
the Company's investor relations information line at 877-8IR-SCIOS (7246) or
send an e-mail to investor_relations@sciosinc.com.
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.
SOURCE Scios Inc.
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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, both of Lazar Partners Ltd., +1-212-867-1762
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