On April 23, 2013, CEL-SCI Corporation announced that the company hired two clinical research organizations, Aptiv Solutions and Ergomed, to manage the Multikine phase III study. Both CROs will help CEL-SCI expand the trial by 60 to 80 clinical sites globally. Aptiv Solutions and Ergomed have replaced the CRO currently managing the study.
Under a co-development agreement, Ergomed, which will be responsible for most of the new patient enrollment, will contribute up to $10 million towards the study. Ergomed will perform clinical services in exchange for milestone and royalty payments (single digit %) up to a specified maximum amount.
To date, the phase III trial has enrolled 117 patients at 39 centers in eight countries, including three centers in Israel, and nine centers in Taiwan.