UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer
December 04 2023 - 8:30AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today announced
that the British National Institute for Health and Care Excellence
(NICE) has selected Multikine* (Leukocyte Interleukin, Injection)
to be evaluated as the potential new standard of care for squamous
cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted
a detailed report from the UK’s National Institute for Health and
Care Research (NIHR) regarding Multikine, its clinical data, and
its potential to become a better standard of care in treating newly
diagnosed head and neck cancer in the UK. This published report
informs UK doctors, patients, and other interested parties that
NICE has started the review of Multikine and is soliciting public
comment.
As stated on NICE’s website (click here), the reason for
selecting Multikine is the following:
“Anticipate the topic will be of importance to patients, carers,
professionals, commissioners and the health of the public to ensure
clinical benefit is realised, inequalities in use addressed, and
help them make the best use of NHS resources”
A detailed Health Technology Briefing prepared by the NIHR
posted on NICE’s website (click here) titled “Leukocyte interleukin
with cyclophosphamide, indomethacin, and zinc for neoadjuvant
therapy of squamous cell carcinoma of the head and neck” can viewed
in full HERE.
The NICE briefing includes the following statements:
- “The current standard of care for locally advanced SCCHN is an
aggressive combined modality therapy. With current treatment the
risk of recurrence, distant metastases, and death (5-year survival
rate) for patients remains high.”
- “With current standard of care, most patients with SCCHN still
experience disease recurrence or develop distant metastases (spread
to distant organs or lymph nodes), therefore novel treatment
options are needed.”
- “The LI injection [Multikine] utilizes naturally occurring,
immune-regulating cytokines, and could be the first investigational
immunotherapeutic to be used in locally advanced SCCHN. Results
from phase III clinical trial (NCT01265849) indicated a
statistically significant 5-year survival benefit with LI
immunotherapy produced in patients receiving surgery plus
radiotherapy, representing approximately 40% of the study
population.”
- “If licensed, LI [Multikine] will offer the first-line
neoadjuvant treatment in previously untreated patients with SCCHN
prior to standard of care.”
Dr. Mehmet Sen, MD, FRCR, one of Europe’s leading head and neck
oncologists treating patients for more than 30 years, and
Consultant Clinical Oncologist and Honorary Senior Lecturer at the
St. James Institute of Oncology in Leeds, UK, commented, “There is
a clear and imperative need for a new treatment for newly diagnosed
head and neck cancer patients in the UK and worldwide. Multikine’s
efficacy and safety data are clear and compelling. Moreover,
because Multikine can be administered before the current standard
of care of surgery and radiation, it has strong potential to be
additive to survival at minimal additional risk, if any, to the
patient.”
“We are highly encouraged that NICE has selected Multikine for
evaluation as a potential new standard of care for head and neck
cancer. This is a big step forward in the UK,” stated CEL-SCI CEO
Geert Kersten.
NICE is an executive non-departmental public body of the
Department of Health and Social Care in the UK. NICE publishes
guidelines in four areas:
- the use of health technologies within England's National Health
Service (NHS) and NHS Wales (such as the use of new and existing
medicines, treatments and procedures)
- clinical practice (guidance on the appropriate treatment and
care of people with specific diseases and conditions)
- guidance for public sector workers on health promotion and
ill-health avoidance
- guidance for social care services and users.
These appraisals are based primarily on evidence-based
evaluations of efficacy, safety and cost-effectiveness in various
circumstances.
According to Cancer Research UK, an average of 12,400 cases of
head and neck cancer are diagnosed each year in the UK.
About CEL-SCI Corporation
CEL-SCI is a clinical-stage biotechnology company focused on
activating the immune system of cancer patients to fight cancer
before surgery, radiation and chemotherapy have damaged it. The
Company’s lead investigational therapy Multikine completed a
pivotal Phase 3 clinical trial involving head and neck cancer, for
which the Company has received Orphan Drug Status from the FDA. The
Company has operations in Vienna, Virginia, and 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.
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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