CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head & Neck Cancer
September 26 2023 - 8:00AM
Business Wire
Europe has 150,000 new head & neck
cancer cases each year, more than twice the incidence in the
U.S.
CEL-SCI Corporation (NYSE American: CVM) today reported
it has filed a request for Scientific Advice regarding Multikine*
(Leukocyte Interleukin, Injection) immunotherapy for the treatment
of newly diagnosed locally advanced squamous cell carcinoma of the
head and neck (SCCHN) with the European Medicines Agency’s (EMA’s)
Scientific Advice Working Group.
Europe is a high priority market for CEL-SCI, as Europe has
150,000 new annual cases of head and neck cancer, more than twice
the 68,000 cases diagnosed each year in the U.S.
“We look forward to discussing with the Scientific Advice
Working Group the positive clinical data from our completed Phase 3
study of Multikine in head and neck cancer. The goal is to obtain
the Working Group’s opinion regarding this information and reach an
agreement with them on a plan which will allow us to file for
marketing authorization in the EU as soon as possible” stated
CEL-SCI’s CEO Geert Kersten. “This is part of our global regulatory
approval strategy. We concurrently plan to pursue filings for
marketing authorization in multiple countries. There is no question
about the dire need for a new and effective treatment for newly
diagnosed SCCHN patients, and we are hopeful that regulators will
appreciate the robust data and results from our Phase 3 study that
demonstrate Multikine’s efficacy and safety.”
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 studied patients
who were newly diagnosed with locally advanced primary squamous
cell carcinoma of the head and neck (oral cavity and soft-palate)
with the investigational product Multikine first, BEFORE they
received surgery and radiotherapy or surgery plus concurrent
radiotherapy and chemotherapy (the current standard of care for
these patients). We believe this approach is unique. Most other
cancer immunotherapies are administered only after conventional
therapies have been tried and/or failed.
Multikine is designed to help the immune system “target” the
tumor at a time when the immune system is still relatively intact
and thereby thought to be better able to mount an attack on the
tumor. The Phase 3 study enrolled 928 patients.
Multikine (Leukocyte Interleukin, Injection) received Orphan
Drug designation from the FDA for neoadjuvant therapy in patients
with squamous cell carcinoma (cancer) of the head and neck.
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. 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.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. 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'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, 2022. 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. 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.
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Gavin de Windt CEL-SCI Corporation (703) 506-9460
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