Henry Ford Health System of Detroit to Enroll and Treat Patients in CEL-SCI’s Phase III Head and Neck Cancer Clinical Trial
April 08 2014 - 9:00AM
Business Wire
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
the Henry Ford Health System in Detroit, Michigan is the latest
U.S. clinical center to join the Company’s Phase III head and neck
cancer clinical trial of its investigational cancer immunotherapy
treatment Multikine* (Leukocyte Interleukin, Injection). CEL-SCI is
currently expanding and accelerating patient enrollment in its
trial. The Company expects to rapidly expand the number of clinical
sites active in the U.S. As the world’s largest Phase III trial for
head and neck cancer, CEL-SCI’s study is already active in dozens
of clinical centers in 12 countries and is expected to expand to a
total of 20 countries by the end of 2015.
CEL-SCI’s Multikine investigational cancer immunotherapy is
intended to create an anti-tumor immune response to reduce
local/regional tumor recurrence and thereby increase the survival
rate of patients. 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.
According to a report published by the Metropolitan Detroit
Cancer Surveillance System in 2010, there were 24,651 new invasive
and in situ cancers diagnosed in residents of the metropolitan
Detroit area of Wayne, Oakland, and Macomb Counties. In a national
study researchers estimated that more than 52,000 men and women
would be diagnosed in the U.S. with head and neck cancers in 2012,
according to the National Cancer Institute.
Founded in 1915 by auto pioneer Henry Ford and now one of the
nation's leading health care providers, Detroit’s Henry Ford Health
System is comprised of hospitals, medical centers and one of the
nation's largest group practices, which includes more than 1,200
physicians practicing in over 40 specialties.
The Josephine Ford Cancer Institute at Henry Ford is a leader in
groundbreaking techniques, offering the most advanced diagnostic
testing, and multiple treatment approaches including surgery and
radiation therapy. Dr. Haythem Ali, a medical oncologist, is the
Principal Investigator for CEL-SCI’s study at Henry Ford. His
specialties include head and neck cancer and he has published
several articles in peer reviewed journals.
“This is our first U.S. clinical center to open in the Midwest.
Our intention is to rapidly add more clinical research centers
located across North America so that patients seeking to enroll in
our immunotherapy trial may have the opportunity to access a site.
We are pleased that Dr. Haythem and one of the leading healthcare
providers in the country, Henry Ford Health System, have chosen to
participate in our groundbreaking study,” stated CEL-SCI Chief
Executive Officer Geert Kersten.
About Multikine Phase III Study
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.
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.
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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