CEL-SCI Expands Its Pivotal Phase III Immunotherapy Head and Neck Cancer Trial With Addition of 7 More Clinical Sites
December 08 2014 - 8:45AM
Business Wire
Sites in Europe and Asia add to patient
enrollment and position Company to apply for global regulatory
approvals
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
during November it has added seven new clinical sites to its global
pivotal Phase III head and neck cancer trial for its
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection). Patient screening has begun at new clinical centers in
France, Turkey, Poland, Sri Lanka, Russia and Taiwan.
“The addition of these seven centers is one of the ways in which
we intend to increase patient enrollment beyond the 800%
year-over-year increase we have already achieved between 2013 and
2014. By conducting a study on this global scale, in the U.S. and
about 20 other countries, we are not only increasing the speed of
enrollment, but are also positioning CEL-SCI, pending favorable
clinical results, to apply for marketing approval in the U.S. and
the majority of regulatory agencies around the world,” stated
CEL-SCI Chief Executive Officer Geert Kersten.
A total of 880 patients are expected to be enrolled through over
100 clinical sites in about 20 countries by the end of 2015 in the
world’s largest Phase III trial for head and neck cancer.
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 the 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 an
open-label, 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 120 clinical
centers in over 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
HIV/HPV co-infected and for peri-anal warts in men and women who
are HIV/HPV co-infected.
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.
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 National Institutes of
Health to develop LEAPS as a potential treatment for RA with
researchers from Rush University Medical Center in Chicago,
Illinois. 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, 703-506-9460
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