CEL-SCI Presents Phase 3 Multikine Head & Neck Cancer Data at ASCO
June 07 2022 - 7:30AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today announced
that its abstract and poster titled “Leukocyte interleukin
injection (LI) immunotherapy extends overall survival (OS) in
treatment-naive low-risk (LR) locally advanced primary squamous
cell carcinoma of the head and neck: The IT-MATTERS study” was
presented on June 6, 2022 at the American Society of Clinical
Oncology (ASCO)’s 2022 ASCO Annual Meeting in Chicago,
Illinois.
Presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor,
Ph.D., to the largest gathering of cancer experts from academia,
industry, patient advocacy and policy, the poster provided detailed
data on Multikine®’s (Leukocyte Interleukin, Inj.)* efficacy in
extending overall survival in treatment-naive low-risk (LR) locally
advanced primary squamous cell carcinoma of the head and neck. The
abstract was selected by ASCO for poster presentation and was well
received by oncology experts at the conference.
Based on the results of this pivotal Phase 3 study, including
data in the ASCO poster presentation, CEL-SCI intends to file a
Biologic License Application with the U.S. Food and Drug
Administration (FDA) for approval of this indication.
Link to poster:
https://cel-sci.com/wp-content/uploads/2022/06/CEL-SCI-ASCO-2022-Poster-6032-June-6-Head-and-Neck-Cancer-1.pdf
Link to ASCO abstract 6032:
https://meetings.asco.org/abstracts-presentations/207201
The conclusions presented in the poster are as follows:
- Safety results were not significantly different between
treatment groups.
- Leukocyte Interleukin, LI (MK) neoadjuvant immunotherapy did
not add excess safety issues or TEAEs.
- In the Randomized ITT population, early LI (MK) response
decreases mortality and is prognostic/predictive of OS.
- ITT Lower Risk LI (MK)+CIZ+SOC absolute OS advantage over SOC
alone (Control) increased over time to 14.1% at 5-years; the 0.68
HR corresponds to a 47% prolongation of median survival, having a
46-month median OS advantage over SOC alone. The SCCHN population
studied has been without any new therapy options in decades.
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. Most
other cancer immunotherapies are administered only after
conventional therapies have been tried and/or failed. 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. CEL-SCI believes that this
Phase 3 study is the largest Phase 3 study in the world for the
treatment of advanced primary head and neck cancer.
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 be better able to mount an attack on the tumor.
The Phase 3 study was started in early 2011 and was fully enrolled
with 928 patients in September 2016. To prove an overall survival
benefit, the study required CEL-SCI to wait until at least 298
(deaths) events had occurred among the two main comparator
groups.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis. 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, 2021. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220607005371/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Sep 2023 to Sep 2024