Cytokine PharmaSciences Completes Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364
Phase II Study in Crohn's disease will be initiated in early 2010
KING OF PRUSSIA, Pa., Nov. 30 /PRNewswire/ --
<!-- cpurl -->Cytokine PharmaSciences<!-- /cpurl -->, Inc. today
announced the completion of a Phase I study of
<!-- ppurl -->CPSI-2364<!-- /ppurl -->, 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.
About CPSI-2364
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 <!-- ppurl -->Cervidil<!-- /ppurl -->®
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.
CONTACT: Dennis F. Willson, President & CEO of Cytokine
PharmaSciences,
Inc., +1-610-687-1776 ext. 211
Web Site: http://www.cytokinepharmasciences.com/
Posted: December 2009
