CEL-SCI
Corporation (NYSE MKT:CVM) today announced that the University
of Cincinnati Cancer Institute is the latest medical center in the
U.S. to join its Phase III head and neck cancer clinical trial of its
investigational cancer immunotherapy treatment Multikine* (Leukocyte
Interleukin, Injection). 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 with an estimated 880 patients to be enrolled by the end of
2015. According to the American
Society of Clinical Oncology, head and neck cancers account for
about 3% to 5% of all cancers in the United States.
The University of Cincinnati’s Comprehensive
Head and Neck Cancer Center offers patient-centered care from a
multidisciplinary team that focuses exclusively on treating cancers of
the head and neck. This includes cancers of the oral cavity (tongue,
jaw, lip, cheek, and hard palate), throat (tonsil, and base of tongue),
larynx (voice box), nose and sinus cavity, skull base, salivary glands,
thyroid gland and parathyroid gland. The clinical team includes head and
neck cancer surgeons, radiation oncologists, medical oncologists, head
and neck radiologists, pathologists, speech therapists and experienced
head and neck cancer nurses.
Dr.
Keith Casper, Co-Director of the Comprehensive Head and Neck Cancer
Center, is the Principal Investigator of CEL-SCI’s Phase III trial at
the University of Cincinnati. Dr. Casper has been a Head and Neck
Surgical Oncologist at UC Health since 2009. He is also an Assistant
Professor of Otolaryngology- Head and Neck Surgery at the University of
Cincinnati College of Medicine.
“The University of Cincinnati Cancer Institute’s Comprehensive Head and
Neck Cancer Center is one of the largest centers in its region
specialized in head and neck cancer. Dr. Casper is a renowned expert and
thought leader in head and neck cancer and we are very pleased to have
his participation in our global 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 press release, 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