CEL-SCI Concludes Positive Meeting With U.S. FDA Concerning Multikine’s Approval for Head & Neck Cancer
14 7월 2023 - 10:15PM
Business Wire
- FDA acknowledges the great need for improved treatments for
head and neck cancer, particularly the locally advanced oral cavity
that CEL-SCI is targeting and is open to a close collaboration with
CEL-SCI to help demonstrate that Multikine could be such a
therapy
- Approval is being pursued in other markets including Europe,
the United Kingdom, and Canada, where commercialization could
possibly begin as early as 2024 if Health Canada clears the
submission
CEL-SCI Corporation (NYSE American: CVM) today announced
it has concluded a productive meeting with the U.S. Food and Drug
Administration (FDA) regarding the path forward for bringing
Multikine* (Leukocyte Interleukin, Injection) immunotherapy to
market for the treatment of newly diagnosed locally advanced
squamous cell carcinoma of the head and neck (SCCHN). During the
recent meeting, the FDA acknowledged the longstanding need for
improved treatments for head and neck cancer.
CEL-SCI believes the agency was collaborative and positive.
Preliminary feedback from the FDA included that the selection
criteria developed by CEL-SCI could be used to determine which
patients should receive Multikine. Based on the feedback received
at this recent meeting, CEL-SCI is preparing additional information
about its development plan for the next meeting with the
agency.
CEL-SCI is expecting scientific advice meetings with the
European Medicines Agency (EMA) and the Medicines and Healthcare
Products Regulatory Agency (MHRA) in the UK in the fall of 2023.
These are priority markets for CEL-SCI, as Europe has more than
twice the number of head and neck cancer cases diagnosed each year
as compared to the U.S.
The Company believes that it is even further along the
regulatory path in Canada, as Health Canada already advised CEL-SCI
earlier this year that it would be appropriate to request advance
consideration for approval of Multikine under the Notice of
Compliance with Conditions (NOCC) policy. If Health Canada grants
the NOCC, then it is possible that CEL-SCI could begin
commercialization in Canada as early as 2024.
Geert Kersten, CEO of CEL-SCI stated, “The almost 4-year median
survival benefit and complete tumor elimination in some patients in
just 3 weeks are very strong indications that we have a drug that
can help patients with this horrible cancer. It is also important
to note that 15.2% of the patients treated with Multikine exhibited
a tumor response in only 3 weeks and patients who have a tumor
response have an 82.2% survival at 5-years, compared to 48.6% for
the control group. Tumor response has often been used in
conditional approvals as an important indicator of the
effectiveness of a treatment. A confirmatory clinical trial will be
required by the FDA based on the agreed upon selection criteria for
patients that will be treated with Multikine as assessed by methods
including PET-CT/MRI screening. We will collaborate closely with
the FDA to design a clinical protocol that will allow us to
generate, as expeditiously as possible, the confirmatory data they
require for approval of Multikine. This includes confirming the
pre-surgical tumor responses that arise within just weeks of
Multikine treatment in the agreed upon population. Our meeting with
Health Canada earlier this year was also positive, and we are
preparing our application for the NOCC approval as they suggested,
which we hope to file later this year/early next year. Our planned
meetings with the MHRA in Britain and the EMA in Europe will help
us understand if a conditional approval can be given in those
countries with a promise to do confirmatory studies after approval
or if it is possible to get a conditional approval with the
enrollment of just a small number of patients. Our goal is to
obtain approval of Multikine worldwide and then make it available
to patients as fast as possible.”
Multikine is a neoadjuvant immunotherapy given to newly
diagnosed head and neck cancer patients for three weeks immediately
after diagnosis, before the standard of care (SOC) treatments of
surgery and radiation, because that is when the immune system is
still thought to be the strongest. The completed pivotal Phase 3
study demonstrated that patients who received Multikine followed by
surgery and radiation reported a 5-year statistically significant
overall survival (OS) absolute benefit of 14.1% in the intent to
treat (ITT) subjects (n=380) who were categorized as lower risk for
recurrence (LR) per National Comprehensive Cancer Network (NCCN)
guidelines as compared to control LR subjects who received only
SOC. With PET-CT/MRI, these subjects can be identified at screening
to permit Multikine treatment before surgery.
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 studied patients
who were newly diagnosed with locally advanced primary squamous
cell carcinoma of the head and neck (oral cavity and soft-palate)
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). We believe that this approach is unique. Most
other cancer immunotherapies are administered only after
conventional therapies have been tried and/or failed.
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. The Phase 3 study enrolled 928 patients.
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.
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, 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
Cel Sci (AMEX:CVM)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Cel Sci (AMEX:CVM)
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부터 5월(5) 2023 으로 5월(5) 2024