CEL-SCI Reports Record Monthly Patient Enrollment in April for Its Phase 3 Head and Neck Cancer Trial
May 02 2016 - 8:00AM
Business Wire
CEL-SCI Corporation (NYSE MKT:CVM) ("CEL SCI" or the
"Company") today announced that during the month of April it has
enrolled 41 patients in its ongoing Phase 3 trial of its
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection) in patients with advanced primary head and neck cancer.
This is a new monthly enrollment record, surpassing the prior
record of 38 patients enrolled in October 2015. Total patient
enrollment for the trial is now 797 as of April 30, 2016.
About the Multikine Phase 3 StudyThe 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 MultikineMultikine (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.
CEL-SCI has entered into a $12 million co-development agreement
with Ergomed Clinical Research Limited for the ongoing Phase 3
clinical trial against head and neck cancer. CEL-SCI has also
entered into two additional co-development agreements for up to $3
million each with Ergomed to further the development of 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 CorporationCEL-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 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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version on businesswire.com: http://www.businesswire.com/news/home/20160502005430/en/
CEL-SCI CorporationGavin de Windt,
703-506-9460www.cel-sci.com
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