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-H1N1-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.
Copyright Business Wire 2014