EXHIBIT 99.1
NEWS
RELEASE
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8229
Boone Boulevard, Suite 802
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COMPANY
CONTACT:
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Vienna,
VA 22182. USA
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Gavin
de Windt
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Telephone
(703) 506-9460
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CEL-SCI
Corporation
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www.cel-sci.com
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(703)
506-9460
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CEL-SCI REPORTS RECENT DATA REVIEW BY THE INDEPENDENT DATA
MONITORING COMMITTEE FOR ITS PIVOTAL PHASE 3 HEAD AND NECK CANCER
STUDY
Vienna, VA, October 15 , 2019 -- CEL-SCI Corporation
(NYSE American: CVM)
announced today that the Independent Data Monitoring Committee
(IDMC) for the Company's pivotal Phase 3 head and neck cancer study
of its investigational immunotherapy Multikine* (Leukocyte
Interleukin, Injection) has completed its recent review of the
Phase 3 study data. The IDMC meets periodically to review the
safety and efficacy of the ongoing Phase 3 study.
The
data from all 928 enrolled patients were provided to the IDMC by
the clinical research organization (CRO) responsible for data
management of this Phase 3 study. At the most recent IDMC meeting
in October 2019 the IDMC reviewed “progression free and
overall survival and limited demographic and safety data available
for the aforementioned protocol.”
The
IDMC made the following recommendation:
●
The IDMC
recommendation “is to continue the trial until the
appropriate number of events has occurred”.
IDMCs
are committees commonly used by sponsors of clinical trials to
protect the interests of the patients and the integrity of the
study data in ongoing trials, especially when the trials involve
patients with life threatening diseases, and when, as in cancer
clinical trials, they extend over long periods of
time.
About CEL-SCI Corporation
CEL-SCI
believes that boosting a patient’s immune system while it is
still intact should provide the greatest possible impact on
survival. Therefore, in the Phase 3 study CEL-SCI treats patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with the investigational product
Multikine first, BEFORE they receive surgery, radiation and/or
chemotherapy. This approach is unique. Most other cancer
immunotherapies are administered only after conventional therapies
have been tried and/or failed. Multikine (Leukocyte Interleukin,
Injection), has received Orphan Drug designation from the FDA for
neoadjuvant therapy in patients with squamous cell carcinoma
(cancer) of the head and neck.
CEL-SCI
believes that this Phase 3 study is the largest Phase 3 study in
the world for the treatment of head and neck cancer. Per the
study’s protocol, newly diagnosed patients with advanced
primary squamous cell carcinoma of the head and neck are treated
with the Multikine treatment regimen for 3 weeks prior to receiving
the Standard of Care (SOC) which involves surgery, radiation or
concurrent radiochemotherapy. Multikine is designed to help the
immune system “see” the tumor at a time when the immune
system is still relatively intact and thereby thought to better be
able to mount an attack on the tumor. The aim of treatment with
Multikine is to boost the body’s immune system prior to SOC.
The Phase 3 study is fully enrolled with 928 patients and the last
patient was treated in September 2016. To prove an overall survival
benefit, the study requires CEL-SCI to wait until 298 events have
occurred among the two main comparator groups.
The
Company’s experimental LEAPS technology is currently being
developed as a potential therapeutic vaccine for rheumatoid
arthritis and is supported by grants from the National Institutes
of Health. The Company has operations in Vienna, Virginia, and near
Baltimore, Maryland.
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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,
including statements with respect to Multikine and the Phase 3
clinical trial of Multikine in patients with advanced primary
squamous cell carcinoma of the head and neck. 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 trials or nonclinical
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’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, 2018. 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 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. 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 in
progress.
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