CEL-SCI Reports Monthly Patient Enrollment in November for Its Phase 3 Head and Neck Cancer Trial
December 01 2015 - 10:30AM
Business Wire
CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the
"Company") today announced that in the month of November it has
enrolled 27 patients in its ongoing Phase 3 trial of its
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection) in patients with advanced primary head and neck cancer.
Total patient enrollment is now 635 as of November 30, 2015 in the
world’s largest Phase 3 study in head and neck cancer.
“This fall we have been enrolling patients at an average of rate
one per day. We expect this rate will significantly increase in the
first quarter of 2016 based on the number of new clinical centers
that are now being activated,” stated CEL-SCI CEO Geert
Kersten.
The current study goal is to enroll 880 patients through
approximately 100 clinical centers in over 20 countries.
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling patients with advanced
primary squamous cell carcinoma of the head and neck. 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 3 clinical
trial as a potential first-line treatment for advanced primary
squamous cell carcinoma of the head and neck. Multikine is designed
to 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.
Multikine is also being tested in a Phase 1 study under a
Cooperative Research and Development Agreement ("CRADA") with the
U.S. Naval Medical Center, San Diego, and at University of
California, San Francisco (UCSF), as a potential treatment for
peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel
Palefsky, a world renowned scientist and Key Opinion Leader (KOL)
in human papilloma virus (HPV) research and the prevention of anal
cancer, is the Principal Investigator at UCSF, which was added to
the study in July 2015.
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 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. If the study
endpoint, which is a 10% improvement in overall survival of the
subjects treated with the Multikine treatment regimen plus the
current standard of care (SOC) as compared to subjects treated with
the current SOC only, is satisfied, the study results will be used
to support applications that the Company plans to submit to
regulatory agencies in order to seek commercial marketing approvals
for Multikine in major markets around the world. Additional
clinical indications for Multikine that are being investigated
include the treatment of 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 1 trial of the former indication has been
completed at the University of Maryland. The latter indication is
now in a Phase 1 trial in conjunction with the U.S. Naval Medical
Center, San Diego, under a CRADA and UCSF.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand
Epitope Antigen Presentation System) technology for the potential
treatment of pandemic influenza in hospitalized patients and as a
potential vaccine for the treatment of rheumatoid arthritis.
The Company has operations in Vienna, Virginia, and in/near
Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. When used in this press release, 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 that 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 filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-K and 10-K/A 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.
*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 the Company's 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 have 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 Phase 3 clinical trial of
this investigational therapy that is currently in progress.
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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