FDAnews
www.fdanews.com/articles/71593-vical-advancing-to-phase-ii-trial-with-bivalent-cmv-vaccine

Vical Advancing to Phase II Trial With Bivalent CMV Vaccine

April 27, 2005

Vical has announced that data from two Phase I trials support the advance of the bivalent (two-plasmid) formulation of the company's vaccine against cytomegalovirus (CMV) to Phase II trials in hematopoietic cell transplant (HCT) patients.

The company initiated a Phase I clinical trial with a bivalent formulation of the CMV immunotherapeutic vaccine in March 2004, and a Phase I clinical trial with a trivalent (three-plasmid) formulation of the CMV immunotherapeutic vaccine in September 2004.

Both trials tested two dosing levels and two dosing schedules, with approximately half of the subjects in each trial having prior exposure to CMV (seropositive) and half with no evidence of prior exposure (seronegative).