CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress
10 Settembre 2024 - 3:32PM
Business Wire
Data to be presented on Saturday, September
14 and published via a press release before the open of market on
Monday, September 16
CEL-SCI Corporation (NYSE American: CVM) today reported
it will report new data from its Phase 3 study of Multikine
(Leukocyte Interleukin, Injection)* at the European Society for
Medical Oncology (ESMO) 2024 Congress which takes place from
September 13 – 17, 2024 in Barcelona, Spain. A poster titled
“Prognostic significance of diagnostic staging in treatment naïve,
resectable locally advanced primary oral cavity squamous cell
carcinoma for neoadjuvant Leukocyte Interleukin Injection
immunotherapy” will be presented by the study’s co-author József
Tímár MD, PhD, DSc, a prominent and highly respected
pathologist.
CEL-SCI has received the go-ahead from the U.S. Food and Drug
Administration (FDA) to commence a confirmatory Registration Study
of Multikine in the treatment of head and neck cancer based on
strong safety and efficacy data from its IT-MATTERS completed Phase
3 study.
Dr. Timar is Professor Department of Pathology, Forensic and
Insurance Medicine at Semmelweis University in Budapest, Hungary,
and served as the Director of the Central Pathology Laboratory for
the IT-MATTERS study. With 174 peer reviewed studies published, Dr.
Timar is a founding editor, editor in chief, or a member of the
editorial board of four oncology journals. He is the recipient of a
dozen honors and awards for excellence in cancer research and
teaching.
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. 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.
Multikine (Leukocyte Interleukin, Injection), a true first-line
cancer therapy, has been dosed in over 740 patients and received
Orphan Drug designation from the FDA for neoadjuvant therapy in
patients with squamous cell carcinoma (cancer) of the head and
neck. Multikine significantly extended life in its target patient
population demonstrating a 73% survival rate with Multikine vs.
only 45% without Multikine at 5 years after treatment. Based on
this very strong data, the FDA agreed to CEL-SCI’s target patient
selection criteria and gave the go-ahead to conduct a small,
focused, confirmatory Registration Study which will enroll 212
patients. CEL-SCI will enroll newly diagnosed locally advanced
primary head and neck cancer patients who present with no lymph
node involvement (determined via PET scan) and with low PD-L1 tumor
expression (determined via biopsy), representing over 100,000
patients (globally) annually.
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.
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, 2023. 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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