CEL-SCI Receives Regulatory Clearance to Expand CEL-SCI’S Phase III Head and Neck Cancer Trial into Austria
July 08 2014 - 8:15AM
Business Wire
CEL-SCI Corporation (NYSE MKT:CVM) today announced that
it has received regulatory clearance from the Austrian Federal
Office for Safety in Health Care to begin patient enrollment in the
Company’s Phase III Head and Neck Cancer clinical trial of its
investigational cancer immunotherapy treatment Multikine*
(Leukocyte Interleukin, Injection). Austria is the 14th country to
participate in CEL-SCI’s trial which is already active in numerous
clinics around the world.
CEL-SCI’s Phase III trial is assessing the use of the Company’s
Multikine immunotherapy as a first line treatment for patients
diagnosed with advanced primary head and neck cancer, prior to
standard of care, which involves surgery, chemotherapy, and/or
radiation therapy. 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.
There were more than 150,000 new patients diagnosed with head
and neck cancer in Europe in 2012 according to the European Head
and Neck Society’s (EHNS) Makes Sense Campaign, sponsor of the 2nd
Annual European Head and Neck Cancer Awareness Week September 22 –
26, 2014. The goal of the Makes Sense Campaign is to raise
awareness of head and neck cancer symptoms in order to drive
earlier diagnosis, which is a key factor in survival. According to
the Makes Sense Campaign, if patients are diagnosed in the early
stages of the disease there is an 80–90% survival rate. However 60%
of people with head and neck cancer present with locally advanced
disease at diagnosis, and 60% of those people diagnosed at an
advanced stage die from the disease within five years. Key risk
factors, as identified by the Makes Sense Campaign are smoking,
alcohol, and human papillomavirus virus (HPV).
“There is growing awareness in Europe of head and neck cancer,
as well as our Phase III immunotherapy study for the disease. We
recently were a Gold Sponsor of the European Congress on Head and
Neck Oncology 2014 conference, which was also sponsored by the
European Head and Neck Society. We are encouraged to see that the
increasing number of head and neck oncologists, who already have
experience with Multikine, are looking to enroll more of their
patients in our study,” stated CEL-SCI Chief Executive Officer
Geert Kersten.
Further expansion of CEL-SCI’s Phase III head and neck cancer
trial is underway with a goal to have a total of 880 patients
enrolled through about 100 clinical centers through by the end of
2015. Over 200 patients are already enrolled in, and being treated
with Multikine.
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 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’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 receive 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 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,
703-506-9460www.cel-sci.com
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