Southern Illinois University School of Medicine Becomes Clinical Site for CEL-SCI’s Global Phase III Immunotherapy Head & N...
April 28 2014 - 8:30AM
Business Wire
Estimated 52,000 new cases of head and neck
cancer are diagnosed each year in the U.S.
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.
CEL-SCI CorporationGavin de Windt, 703-506-9460
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