Discussion of Results of CEL-SCI’s Phase 3 Trial Is Now Available
July 02 2021 - 11:20AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today announced
that the discussion at the Annual Shareholder Meeting, on July 1,
2021 at 10:00 am EDT, regarding its Phase 3 head and neck cancer
trial results is available at
https://edge.media-server.com/mmc/p/ou79u5bv.
The discussion on the Phase 3 results was presented by Geert
Kersten the Chief Executive Officer, Dr. Eyal Talor the Chief
Scientific Officer and John Cipriano the Senior Vice President of
Regulatory Affairs. In the landmark Phase 3 study, Multikine®
produced a significant 14.1% 5-year survival benefit (62.7% vs
48.6%) in the group of advanced primary head and neck cancer
patients who received surgery plus radiotherapy. The Company plans
to file for FDA approval in this patient population.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an
investigational cancer immunotherapy that is known to contain 14
natural human cytokines, the body’s immune system regulators
including interleukins, interferons, chemokines, and colony
stimulating factors which are elements of the body’s natural mix of
defenses against cancer and other diseases. A patented,
mass-produced, off the shelf and ready to use non-autologous
biological product, Multikine is manufactured using a proprietary
process following Good Manufacturing Practice (GMP) requirements
from Source Leukocytes, an FDA licensed product, at CEL-SCI’s
manufacturing facility near Baltimore, Maryland.
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 and radiotherapy or
surgery plus concurrent radiotherapy and chemotherapy (the current
standard of care for these patients). This approach is unique. The
study showed excellent survival benefit for those patients who
received Multikine plus surgery and radiation. When chemotherapy
was added the survival benefit was negated.
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 and statements made at the annual meeting may
contain 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. Words when used in
this press release and at the annual meeting, such as "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, 2020. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210702005311/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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