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Southern Illinois University School of Medicine Becomes

Clinical Site for CEL-SCIs Global Phase III


Immunotherapy Head and Neck Cancer Trial
VIENNA, Va.--(BUSINESS WIRE)--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.
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a
randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for
advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's
clinical development program for head and neck cancer, Multikine would be a different type of
therapy in the fight against cancer; one that appears to have the potential to work with the body's
natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of
subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to
expand into a total of approximately 100-110 clinical centers in about 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and
Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a
potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also
announced that it entered into two new co-development agreements with Ergomed to further
clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV
and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer
and other diseases by utilizing the immune system, the body's natural defense system. Its lead
investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a
pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N-
-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for
Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The
investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1
Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned
about the possible emergence of a new more virulent hybrid virus through the combination of H1N1
and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near
Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this
proprietary name is subject to FDA review in connection with our future anticipated regulatory
submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by
the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for
any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data
involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research
is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III
clinical trial of this investigational therapy that is currently in progress.
Safe Harbor Statement
When used in this report, the words "intends," "believes," "anticipated," "plans" and "expects" and
similar expressions are intended to identify forward-looking statements. Such statements are subject
to risks and uncertainties which could cause actual results to differ materially from those projected.
Factors that could cause or contribute to such differences include, an inability to duplicate the
clinical results demonstrated in clinical studies, timely development of any potential products that
can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in
manufacturing any of the Company's potential products, inability to raise the necessary capital and
the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not
limited to its report on Form 10- K for the year ended September 30, 2013. The Company undertakes
no obligation to publicly release the result of any revision to these forward-looking statements which
may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence
of unanticipated events.
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