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Cytokine Announces Oral Efficacy of Anti-Cytokine Semapimod
Date:10/29/2007

KING OF PRUSSIA, Pa., Oct. 29 /PRNewswire/ -- Cytokine PharmaSciences, Inc. (CPSI) today announced development of an orally active form of semapimod, its synthetic anti-cytokine compound. Semapimod is a potential treatment for inflammatory and autoimmune diseases including rheumatoid arthritis, Crohn's and psoriasis. The compound has previously been tested in clinical trials only as an intravenous infusion and the newly developed oral form should significantly enhance its acceptability to patients and physicians.

Semapimod is a synthetic guanylhydrazone that inhibits the activity of various kinases, including Raf kinase, a key enzyme in the MAPK/ERK signal transduction pathway. Semapimod's inhibition of Raf-kinase decreases phosphorylation of MEK, thereby also inhibiting phosphorylation of p38 MAP kinase. This halts production of several important inflammatory cytokines, including TNF-alpha, IL-1, and IL-6. Preclinical studies have repeatedly demonstrated semapimod's efficacy in animal models of inflammatory and proliferative diseases, including endotoxic shock and toxicity, pancreatitis, ischemia and stroke, necrotizing enterocolitis, and neointimal formation. Despite early signals of efficacy, the Phase II studies CPSI conducted in Crohn's disease were dose-limited by local reactions (i.e., phlebitis) to the semapimod-HCl formulation. These reactions led to the need to develop a less irritating intravenous (IV) form. In response, CPSI has developed a new salt form of semapimod with a dramatically improved solubility and tolerability profile, which ultimately resulted in the new orally available formulation.

Dr. Daan W. Hommes, (University of Leiden; formerly with the Academic Medical Center, Amsterdam, The Netherlands) tested an IV formulation of semapimod in an early Crohn's disease study. He commented: "The early work with semapimod showed the promise of this drug. Continued development would benefit from improved dosing regimens."

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SOURCE Cytokine PharmaSciences, Inc.
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