CEL-SCI Corporation (NYSE MKT: CVM) today announced its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) has activated another U.S. clinical site at Southern Illinois University School of Medicine’s Simmons Cancer Institute in Springfield, Illinois. The Illinois site, which has become part of the world’s largest Phase III trial for head and neck cancer with dozens of hospitals and clinical centers in 12 countries, has now officially joined the study. According to the National Cancer Institute, researchers estimated that about 52,000 men and women in the U.S. will be diagnosed with head and neck cancers annually.
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. CEL-SCI’s Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.
Southern Illinois University School of Medicine’s SIU HealthCare is the University’s health care practice which served over 477,000 patients in 2013. SIU HealthCare has nearly 240 teaching physicians providing new treatments and technologies that have transformed the practice of medicine. SIU HealthCare’s clinical outreach extends to approximately 100 sites in 46 Illinois communities.
Dr. Krishna A. Rao, M.D., Ph.D., will serve as the Principal Investigator for the CEL-SCI’s Phase III head and neck cancer trial at Southern Illinois University School of Medicine. Dr. Rao is an Associate Professor of hematology and medical oncologist specializing in head and neck cancer. Previously, he was at Fred Hutchinson Cancer Research Center in Seattle, Washington, where he completed a four-year fellowship in hematology and medical oncology. Dr. Rao completed his internal medicine residency at Mayo Graduate School of Medicine in Rochester, Minnesota.
“We are pleased to have the opportunity to enroll patients from Illinois into our Phase III trial which offers a potential new way to treat cancer by using the body’s own natural immune system as a first-line treatment. The clinical investigators at Southern Illinois University School of Medicine will be a key part of our global trial which is designed to include over 100 centers across the world, with ten to twelve of them being in the U.S. Our intention is to rapidly add numerous additional clinical sites in the U.S. and accelerate patient enrollment in this country,” stated CEL-SCI Chief Executive Officer Geert Kersten.
