EXHIBIT 99
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NEWS
RELEASE
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8229
Boone Boulevard, Suite 802
Vienna,
VA 22182. USA
Telephone
(703) 506-9460
www.cel-sci.com
|
COMPANY
CONTACT:
Gavin
de Windt
CEL-SCI
Corporation
(703)
506-9460
|
CEL-SCI Announces Update on Phase 3 Cancer Trial
Results
Data lock is complete, final statistical analysis being
conducted
Vienna, VA, December 7, 2020 -- CEL-SCI Corporation (NYSE American: CVM) announced today
that the Phase 3 study is in the final stage of review which
involves statistical analysis of all study data. Data lock has
already been completed.
Since
the required number of events to allow statistical analysis of
CEL-SCI’s Phase 3 study in head and neck cancer was reached
earlier this year, the Clinical Research Organizations (CROs)
managing CEL-SCI’s Phase 3 study, Ergomed and ICON, had been
performing data base lock of the study results. Data base lock is a
very important and time intensive process that needs to be
completed to ensure any study’s data are accurate and as
complete as possible before the results of the study can be
statistically evaluated and reliable conclusions drawn regarding
the study’s outcome(s). This process was particularly
complicated for CEL-SCI’s Phase 3 study because the study was
conducted in over 20 countries on three continents, and many of
these countries had, and still have, severe shutdowns due to the
COVID-19 pandemic.
The
statistical analysis of our Phase 3 study data is being performed
according to a statistical analysis plan that was approved in
advance of data lock. The analysis is being conducted by
independent unbiased contractors. CEL-SCI is not involved in this
process. Once the analysis has
been completed, CEL-SCI will become privy to the study results. At
that time, shareholders will be advised of the results through a
public announcement. CEL-SCI also plans to publish the results in
peer reviewed scientific journals.
“Our
goal has been to create a cancer drug that is both non-toxic and
works with the body’s immune system to increase the
‘intent to cure’ success rate of the first-line cancer
treatment. We believe that immunotherapy should be administered
before, not after, surgery, radiation and chemotherapy have damaged
the immune system. We further believe that success in head and neck
cancer should lead to many new ways of helping cancer
patients.” said Geert Kersten, CEO of CEL-SCI Corporation.
“We are grateful to our shareholders for believing in us and
supporting us during the very long Phase 3
study.”
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 treated patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with the investigational product
Multikine* first, BEFORE they received 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 were treated
with the Multikine treatment regimen right after diagnosis and
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 to attack the cancer. 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. This study milestone occurred in late
April 2020. The study is currently in the statistical analysis
phase.
The
Company’s LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment for COVID-19 infection. The
Company has operations in Vienna, Virginia, and near/in 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,
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 trials or nonclinical 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's filings
with the Securities and Exchange Commission, including but not
limited to its report on Form 10-K/A for the year ended September
30, 2019. 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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