CEL-SCI’s Pivotal Phase 3 Study Has Reached the Required Number of Events to Evaluate Data for Multikine in Treatment of He...
May 04 2020 - 07:15AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) announced today
that it has been notified that it has reached the targeted
threshold of 298 events (deaths) required to conduct the data
evaluation for its pivotal Phase 3 head and neck cancer study of
Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The
database is now being prepared for database lock. Once the database
has been locked the final analysis of the trial results can be
performed. CEL-SCI will continue to remain blinded to the study
results throughout this process. CEL-SCI will be advised of the
results when the analysis is completed and the study results will
be announced to the public and investors at that time.
The CROs involved in study management are generating the
remaining queries, performing source data verification, completing
medical review, and building the final database needed to produce
the final tables, listings, and figures.
Geert Kersten, Chief Executive of CEL-SCI said, “We have
conducted this 928 patient pivotal Phase 3 study for over nine
years because we hope to improve the current standard of care for
advanced primary head and neck cancer. We believe that the
activation of the immune system by Multikine BEFORE the ravages of
surgery, radiation and chemotherapy can improve the survival of
these patients. I am incredibly proud of the dedication of our
amazing team who has made all of this possible.”
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 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 LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment of COVID-19 in hospitalized
and at-high-risk patients. 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 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 amended 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/20200504005155/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460
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