|[January 23, 2014]
CEL-SCI Receives Government Approval in Serbia to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer
VIENNA, Va. --(Business Wire)--
CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has
received approval from the Medicines and Medical Device Agency of Serbia
to begin enrollment of subjects in its Phase III Head and Neck Cancer
clinical trial of its investigational cancer immunotherapy treatment
Multikine* (Leukocyte Interleukin, Injection). Serbia is the 11th
country from which approval to participate in the world's largest Phase
III trial for the treatment of head and neck cancer has been obtained.
The clinical sites in Serbia are expected to become active in the next
few weeks. Approximately 72 of the worldwide total of 880 patients for
the study are expected to be enrolled in Serbia.
Multikine is the first immunotherapeutic agent being developed as a
potential first-line treatment for advanced primary head and neck
cancer. If it were to be approved by regulatory agencies (e.g. FDA) for
use following completion of CEL-SCI's clinical development program,
Multikine would become an additional and different kind of therapy in
the fight against cancer: one that aims to employ our body's natural
ability to fight tumors.
"Immunotherapy has come to be recognized as the next great breakthrough
in cancer therapeutics. Science
Magazine named cancer immunotherapy the Breakthrough of the Year for
2013. The magazine suggests that clinical trials have cemented
immunotherapy's potential in patients and swayed even the skeptics.
Science Magazine also reports that oncologists say a corner has been
turned and we won't be going back. CEL-SCI has been an early participant
in the study of cancer immunotherapeutics and it's very exciting to see
this class of cancer therapies acknowledged for its potential to
transform the treatment of cancer," stated CEL-SCI CEO Geert Kersten.
"We are pleased to advance our Phase III trial, as Serbia becomes the
latest country to participate in this important immunoterapy trial."
To read the Science Magazine article in full, please visit: http://www.sciencemagazinedigital.org/sciencemagazine/20_december_2013?pg=28#pg28.
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, 10% 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. CEL-SCI's Multikine investigational immunotherapy
is intended to create an anti-tumor immune response to reduce
local/regional tumor recurrence and thereby increase the survival rate
of these patients.
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 its 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 release, the words "intends," "believes,"
"anticipated" 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 (News - Alert) 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
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