VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced that Turkey’s Ministry of Health has cleared the company to begin patient enrollment in CEL-SCI’s global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). The Company expects to enroll patients through three clinical centers in Turkey. Turkey thus becomes the 16th country to participate in the world’s largest Phase III head and neck cancer trial.
“As we add more countries and subsequently more clinical centers, we see an acceleration of the pace of the Phase III trial. In the most recently reported three month period, we saw a 93% increase in patient enrollment over the prior three month period,” stated CEL-SCI Chief Executive Officer Geert Kersten. “We are pleased with the progress of our clinical program as we investigate the efficacy of Multikine immunotherapy to treat cancer.”
Head and neck cancer accounts for about 6% of all cancers, with approximately 600,000 new cases reported annually worldwide. CEL-SCI has received U.S. Orphan Drug designation for Multikine in head and neck cancer in the US.
Further expansion of the Phase III trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers by the end of 2015. Over 220 patients have been enrolled in the study to date.
About Multikine Phase III Study
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
