CEL-SCI Granted European Patent for Multikine’s Mechanism of Action in Making Tumors ‘Visible’ to the Immune System
October 10 2017 - 8:30AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM)
announced today that the European Patent Office has issued a new
patent to CEL-SCI for its lead investigational immunotherapy,
Multikine* (Leukocyte Interleukin, Injection), which is currently
in a pivotal Phase 3 trial for head and neck cancer. Patent # EP 1
879 618 B1 is titled, “A Method for Modulating HLA Class II Tumor
Cell Surface Expression With A Cytokine Mixture” addresses
Multikine’s mechanism of action to make tumors more visible to the
immune system.
“This is a key patent which along with the other Multikine
issued patents addresses how Multikine enables the immune system to
recognize and attack the tumor. One way tumor cells evade the
immune system is by expressing human leukocyte antigens (HLA) on
the tumor cell surface, thus appearing as ‘self’ to the immune
cells and therefore the tumor cells are not attacked,” stated Eyal
Talor, PhD, CEL-SCI’s Chief Scientific Officer. “It is important to
note that the tumors of the Multikine-treated responders in our
prior Phase 2 studies had no HLA Class II expressed on the cell
surface following Multikine treatment as compared to controls**.
This points to Multikine’s ability to modulate HLA expression on
the tumor cell surface, thereby allowing the immune system to
recognize and attack the tumor.”
Geert Kersten, CEO of CEL-SCI commented, “As we are now nearing
the end of our Phase 3 study with Multikine in head and neck
cancer, this recently issued European patent is very important. It
further fortifies our IP estate, which includes a number of issued
patents for Multikine in the US, Europe and other major world
markets including Japan and China, where we hope to make Multikine
available to patients, upon regulatory and marketing approval.”
** Timar et al, JCO 2005 (a Pathology Study)
About CEL-SCI Corporation
CEL-SCI's work is focused on finding the best way to activate
the immune system to fight cancer and infectious diseases. Its lead
investigational immunotherapy, Multikine* (Leukocyte Interleukin,
Injection), is currently being studied in a pivotal Phase 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. The study was
designed with the objective that, if the study endpoint, which is
an improvement in overall survival of the subjects treated with the
Multikine treatment regimen plus the current standard of care (SOC)
as compared to subjects treated with the current SOC only, is
satisfied, the study results will be used to support applications
that the Company plans to submit to regulatory agencies in order to
seek commercial marketing approvals for Multikine in major markets
around the world. The Company’s LEAPS technology is being developed
as a therapeutic vaccine for rheumatoid arthritis and is supported
by grants from the National Institutes of Health. CEL-SCI has
patents on Multikine from the US, Europe, China, and Japan.
The Company has operations in Vienna, Virginia, and in/near
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 and 10-K/A for
the year ended September 30, 2016. 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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CEL-SCI CorporationGavin de Windt, 703-506-9460
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