Phase II Clinical Trial Opens for New Oral Rheumatoid Arthritis Treatment

The pharmaceutical company Scios Inc., recently announced enrollment has begun in a Phase IIa clinical trial evaluating a new oral treatment for rheumatoid arthritis (RA) called, SCIO-469, a novel p38 kinase inhibitor.

“SCIO-469 could become a valuable new oral treatment for the millions of RA patients affected by this disease worldwide,” said Darlene P. Horton, M.D., Scios’ Vice President of Medical Affairs.

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. Results are expected to be announced in early 2003.

SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory regulator 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 has shown that SCIO-469 leads to the suppression of TNF-alpha levels over a wide range of doses, and two Phase I studies demonstrated that doses in the ranges tested were well tolerated in healthy volunteers.

Existing protein-based products that antagonize TNF-alpha are prescription products administered only through injection or infusion. If approved, SCIO-469 would be the first specific oral product aimed at reducing TNF-alpha.

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.

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