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.
Copyright Business Wire 2014