CEL-SCI Announces Update on Phase 3 Cancer Trial Results
December 07 2020 - 9:15AM
Business Wire
Data lock is complete, final statistical
analysis being conducted
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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version on businesswire.com: https://www.businesswire.com/news/home/20201207005262/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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