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.
Copyright Business Wire 2014