University of Cincinnati Cancer Institute’s Comprehensive Head and Neck Cancer Center Joins CEL-SCI’S Phase III Trial
May 27 2014 - 8:00AM
Business Wire
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.
CEL-SCI CorporationGavin de Windt,
703-506-9460www.cel-sci.com
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