KING OF PRUSSIA, Pa., Nov. 30 /PRNewswire/ -- Cytokine PharmaSciences, Inc. today announced the completion of a Phase I study of CPSI-2364, its orally active, small-molecule inhibitor of the production of TNF-alpha and other pro-inflammatory cytokines. Results of the safety and tolerability dose escalation study in healthy volunteers confirm the safety of this compound in initial clinical testing.
All 30 enrolled subjects completed the study, including those receiving the highest dose of CPSI-2364 (270 mg), approximately 30 times the dose that animal models predict will be effective. The drug was well-tolerated with a low incidence of mostly mild adverse events.
"We have now demonstrated that CPSI-2364, a more soluble salt form of semapimod, is safe in humans at doses well above those required for efficacy," said Dr. Thais Sielecki, Vice President of Preclinical Development at Cytokine PharmaSciences. "We have also established a target dose range that we believe optimizes the therapeutic index for CPSI-2364 for use in our next stage of clinical testing."
A Phase II study in patients with Crohn's disease is planned for early 2010.
CPSI-2364 is a chemically-modified form of the synthetic guanylhydrozone, semapimod. Semapimod has been shown to inhibit the signal transduction pathways that lead to the production of nitric oxide and important pro-inflammatory cytokines, including TNF-alpha, IL-1, IL-6, and IL-8. Semapimod has demonstrated activity in multiple animal models of inflammation and autoimmune disease, proof-of-concept studies that led to human clinical trials. An intravenous formulation of semapimod was shown to have significant anti-inflammatory activity in Phase II clinical trials in Crohn's disease, psoriasis and ERCP-induced pancreatitis. However, that formulation caused dose-limiting local reactions, such as phlebitis. To overcome this problem, the Company developed CPSI-2364, a more soluble salt of semapimod that makes oral dosing possible. Animal models have confirmed the oral activity of CPSI-2364.
About Cytokine PharmaSciences
Cytokine PharmaSciences, Inc. is a specialty pharmaceutical company engaged in developing anti-inflammatory and autoimmune therapeutics. The Company is headquartered in King of Prussia (near Philadelphia), Pennsylvania. A wholly owned subsidiary, Controlled Therapeutics (Scotland) Limited (CT), is located in East Kilbride (near Glasgow). CT develops and manufactures controlled-release drug delivery products and has a strong focus in the area of women's health, including manufacturing the successful cervical ripening product, the Cervidil® vaginal insert (Propess® in Europe and elsewhere). Cytokine PharmaSciences has three products in clinical development and employs 70 people at its locations in the U.S. and Scotland. For more information, please visit the company's websites at www.cytokinepharmasciences.com and www.ctscotland.com.
SOURCE Cytokine PharmaSciences, Inc.
|SOURCE Cytokine PharmaSciences, Inc.|
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