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news.US-based biotechnology firm CEL-SCI has received clearance from the Ministry of Health of the Republic of Belarus to begin patient enrollment in the Phase III trial of its investigational cancer immunotherapy Multikine (Leukocyte Interleukin, Injection) in Belarus to treat head and neck cancer.
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Belarus is the 21st country to approve the company’s Phase III trial, which is now enrolling patients with advanced primary, not yet treated, head and neck cancer.
CEL-SCI chief executive officer Geert Kersten said: "With the very large increase in enrollment in the study under the new CRO, we now also see strong interest from doctors and clinical centers in other countries too.
"Therefore, we are working on further expanding this global trial beyond the 21 countries in which we are already cleared to conduct the study. We expect that expanding the geography of the trial will yet further accelerate patient recruitment."
The trial’s objective is to show a significant improvement in the overall survival (OS) of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC), compared with patients who are treated with SOC only.
According to the company, patient enrollment in the open-label, randomized, controlled, global Phase III head and neck cancer trial is expected to be completed by the end of 2015.
In October 2013, the company had signed a CRADA with the US Naval Medical Center for the development of Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts.