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.

HAIFA, Israel, April 28, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR) today announced that its new manufacturing facility has received the European Union’s Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III.

The Qualified Person inspection was conducted in line with the European Union’s Good Manufacturing Practice (GMP) legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem’s new facility, equipment, utilities, and quality management systems. Pluristem’s manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.

“This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials,” stated Zami Aberman, Chairman and CEO of Pluristem. “We believe Pluristem’s advanced, commercial scale cell manufacturing facility is one of our Company’s key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward.”

At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem’s facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.

About Pluristem’s 3D Manufacturing

Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem’s manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration and the Paul-Ehrlich-Institute (PEI), Germany’s health authority.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.