Scios Announces Start of Phase II Clinical Trials of New Oral Treatment For Rheumatoid Arthritis

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Scios Announces Start of Phase II Clinical Trials of New Oral

Treatment For Rheumatoid Arthritis

SUNNYVALE, Calif., Feb. 27 /PRNewswire-FirstCall/ -- Scios Inc. (Nasdaq:

SCIO <http://finance./q?s=scio & d=t> - news

<http://biz./n/s/scio.html> ) 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.