CTCE-0214 is designed to trigger trafficking of immune system cells and stem cells, as well as regeneration of white blood cells and platelets.
The company hopes that the phase Ib study will evaluate the safety, pharmacodynamics, and pharmacokinetic profile of CTCE-0214 as a single injection, multi-dose, and in combination with granulocyte colony stimulating factor (G-CSF).
The company commenced dosing the first cohort of subjects in the first of a three stage protocol, undertaken in Tacoma, Washington, that will include at least 50 healthy adult volunteers.
The first stage of the clinical study involves a single dose escalation design followed in stage two by repeat administration up to three doses. The final stage is designed to explore the possible synergy of CTCE-0214 used in conjunction with G-CSF.
Results of a phase Ia trial for CTCE-0214 in June 2005 demonstrated that the drug was associated with significant increases in total white blood cell and neutrophil in subjects in the highest dose cohort, with an increase of over 300% more neutrophils on treatment then on placebo when measured from baseline within six hours of dosing.