|[February 25, 2013]
CEL-SCI Announces Initiation of New Sites for Multikine Phase III Clinical Study for Head and Neck Cancer in Taiwan
VIENNA, Va. --(Business Wire)--
CEL-SCI Corporation�(NYSE MKT: CVM)�announced today that its
Taiwanese partner, Orient Europharma, has added two additional Taiwanese
clinical centers in CEL-SCI's Phase III head and neck cancer clinical
trial for Multikine® (Leukocyte Interleukin, Injection), the
Company's flagship investigational immunotherapy. The first center is
the China Medical University Hospital which is located in Taichung,
Taiwan, and the second center is the Buddhist Tzu Chi General Hospital
which is located in Hualian, Taiwan.
As part of its large Phase III clinical trial with Multikine, CEL-SCI's
partners Teva Pharmaceuticals and Orient Europharma are conducting the
Multikine Phase III clinical study in Israel and Taiwan respectively.
Both partners have already enrolled patients in the study and are adding
clinical sites to further accelerate the enrollment of patients.
Geert Kersten, CEO of CEL-SCI said, "Following the positive safety
finding by the Independent Data and Safety Monitoring Board that
supervises this Phase III clinical trial last fall, we are now in the
process of significantly expanding the study. All efforts are being made
to enroll all 880 patients as quickly as possible."
The Multikine Phase III study is enrolling patients with advanced
primary, not yet treated, head and neck cancer on 3 continents around
the world. The objective of the study is to demonstrate a statistically
significant 10% improvement in overall survival of enrolled patients who
are treated with Multikine plus Standard of Care (SOC) vs. subjects who
are treated with SOC only. The universally accepted current standard of
care for the patient population being enrolled in the CEL-SCI study is
surgery plus radiation or surgery plus concurrent radiation and
chemotherapy, dependent on the risk factors for recurrence found after
surgery. Multikine treated patients receive 15 local injections of
Multikine over a 3 week period prior to standard of care treatment.
Multikine injections are administered in the area around the tumor and
in the area of the adjacent lymph nodes since those two areas are where
the tumor is most likely to recur. Multikine is intended to create an
anti-tumor immune response to reduce local / regional tumor recurrence
and thereby increase the survival of these patients.
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 for use following completion of our
clinical development program, Multikine would become an additional and
different kind of therapy in the fight against cancer: one that employs
our body's natural ability to fight tumors.
Additional information about the Phase III clinical study is available
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.
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" 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, 2012. 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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