CEL-SCI Reports 3rd Consecutive Month of Record Patient Enrollment in 2015 for Its Phase III Head and Neck Cancer Trial
April 01 2015 - 8:45AM
Business Wire
Over 400 patients enrolled in trial as of
March 31st
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
in March it has enrolled 29 patients with advanced primary, not yet
treated, head and neck cancer into its global pivotal Phase III
head and neck cancer trial for its investigational immunotherapy
Multikine* (Leukocyte Interleukin, Injection). March marks the
third consecutive month of record enrollment for CEL-SCI this year
following January and February 2015. 406 patients have been
enrolled in the Phase III study as of March 31, 2015.
“The accelerating pace of enrollment in our trial is very good.
We expect to see continued increases in monthly patient enrollment
throughout the year as new clinical centers are added and as
existing centers gain more experience with Multikine,” stated
CEL-SCI Chief Executive Officer Geert Kersten.
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’s Clinical Research Organization, who runs the
study for CEL-SCI, is aiming to complete enrollment of about 880
patients 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 over 25 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
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, 2014. 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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