CEL-SCI Reports Monthly Patient Enrollment in July for Its Phase 3 Head and Neck Cancer Trial
August 01 2016 - 09:00AM
Business Wire
CEL-SCI Corporation (NYSE MKT:CVM) ("CEL SCI" or the
"Company") today announced that during the month of July it has
enrolled 29 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 for the trial is now 877 as of July 31,
2016.
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling patients with advanced
primary (not yet treated) 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 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 (before
any other, right after diagnosis) 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 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 an 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 has issued
patents on Multikine from the US, Europe, China and Japan.
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 StatementsThis 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 for the year ended September
30, 2015. 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 (Leukocyte Interleukin, Injection) 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. 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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