FDAnews
www.fdanews.com/articles/83203-chemokine-therapeutics-commences-ctce-0214-study

CHEMOKINE THERAPEUTICS COMMENCES CTCE-0214 STUDY

December 16, 2005

Chemokine Therapeutics has initiated a second clinical study of its lead drug candidate CTCE-0214. CTCE-0214 is a drug designed to trigger trafficking of immune system cells and stem cells, as well as regeneration of white blood cells and platelets. The company began dosing the first cohort of subjects in the first of a three-stage protocol that will include at least 50 healthy adult volunteers.

The first stage of the study involves a single dose-escalation design, followed in stage two by repeat administration of up to three doses. The final stage is designed to explore the possible synergy of CTCE-0214 used in conjunction with G-CSF. Overall, the Phase Ib study will allow the company to evaluate the safety, pharmacodynamics, and pharmacokinetic profile of CTCE-0214 as a single-injection, multidose, and in combination with granulocyte colony stimulating factor.