Completion of Phase I study of CPSI-2364 announced by Cytokine PharmaSciences

Dec 1 2009

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.

SOURCE Cytokine PharmaSciences, Inc.