CEL-SCI Reports Monthly Patient Enrollment in May for Its Phase 3 Head and Neck Cancer Trial
June 01 2016 - 8:11AM
Business Wire
Over 800 Patients Are Enrolled In Its Phase
3 Head and Neck Cancer Trial
CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the
"Company") today announced that during the month of May it has
enrolled 19 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 816 as of May 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 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 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 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 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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