University of Minnesota Masonic Cancer Center Joins CEL-SCI’s Phase III Head & Neck Cancer Trial
September 10 2014 - 8:45AM
Business Wire
Masonic Cancer Center is one of only 41
National Cancer Institute-designated comprehensive cancer centers
in the U.S.
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
the University of Minnesota’s Masonic Cancer Center has becomes the
7th clinical site 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 currently being conducted at about 60 active
clinical centers on three continents and is expected to expand from
17 countries to a 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 Masonic Cancer Center creates a collaborative research
environment focused on the causes, prevention, detection, and
treatment of cancer; applying that knowledge to improve quality of
life for patients and survivors; and sharing its discoveries with
other scientists, students, professionals, and the community. It is
one of only 41 institutions in the U.S. to become a National Cancer
Institute-designated comprehensive cancer center. With more than
500 faculty and staff members, the Masonic Cancer Center is home to
some of the world's top cancer researchers.
The Principal Investigator of CEL-SCI’s Phase III study at this
site is Dr. Gautam Jha, Assistant Professor and Medical Oncologist,
at the University of Minnesota’s Medical School. Dr. Jha’s
interests focus on solid tumor oncology including genito-urinary
malignancies and head and neck tumors. His research interests
include developing immune-based therapies by disrupting Treg
mediated immune suppression in patients with cancers of prostate
and head and neck. He is a member of the American Society of
Hematology, the American Society of Clinical Oncology, the American
Association for Cancer Research, and the Society of Immunotherapy
of Cancer.
"Dr. Jha’s research interests and expertise in immunotherapies
for the treatment of head and neck cancer is an asset for our
study, as well as for the patients to be enrolled and treated at
the Masonic Cancer Center,” stated CEL-SCI Chief Executive Officer
Geert Kersten. “We are pleased to see more top-notch cancer centers
joining our clinical trial.”
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
investigational 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 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 U.S.
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’s work is focused on finding the best way to activate
the immune system to fight cancer and infectious diseases. Its lead
investigational therapy Multikine (Leukocyte Interleukin,
Injection) is currently being studied in a pivotal Phase III
clinical trial against head and neck cancer. If the study endpoint,
which is a 10% improvement in overall survival of the subjects
treated with Multikine treatment regimen as compared to subjects
treated with current standard of care only is satisfied, the study
results will be used to support applications which will be
submitted to regulatory agencies in order to request from these
agencies commercial marketing approvals for Multikine in major
markets around the world. Additional clinical indications for
Multikine which are being investigated include cervical dysplasia
in HIV/HPV co-infected women, and the treatment of peri-anal warts
in HIV/HPV co-infected men and women. A Phase I trial of the former
indication has been completed at the University of Maryland. The
latter indication is now in a Phase I trial in conjunction with the
U.S. Navy under a CRADA (Cooperative Research and Development
Agreement).
CEL-SCI is also developing its LEAPS technology for the
treatment of pandemic influenza and as a potential therapeutic
vaccine against rheumatoid arthritis. The Company has recently
received a Phase I SBIR Grant from the NIH to develop LEAPS as a
potential treatment for RA with Rush University researchers. 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, 703-506-9460
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Apr 2023 to Apr 2024