CEL-SCI Files Request With the UK’s MHRA Regarding Path to Approval for Multikine in the Treatment of Head & Neck Cancer
05 10월 2023 - 9:45PM
Business Wire
- CEL-SCI will present the MHRA with new results that
demonstrate pre-surgical response rates and overall survival
advantages that are superior to those published by CEL-SCI
previously, as a result of an improved selection algorithm that
more accurately predicts the patients who would benefit most from
the Multikine therapy
- UK has about 12,500 new head & neck cancer cases each
year
CEL-SCI Corporation (NYSE American: CVM) today reported
it has filed a request with the United Kingdom’s Medicines and
Healthcare Products Regulatory Agency (MHRA) to discuss a pathway
for approval of Multikine* (Leukocyte Interleukin, Injection)
immunotherapy for the treatment of newly diagnosed head and neck
cancer.
At the meeting, CEL-SCI will present MHRA with new results that
demonstrate pre-surgical response rates and overall survival
advantages that are superior to those published by CEL-SCI
previously. These new results arose from an improved selection
algorithm of the Multikine target population. The improvements in
the selection algorithm were based on discussions and feedback from
regulators and consultants. This improved selection algorithm is
able to more accurately predict the patients who would benefit most
from the Multikine therapy.
A statistical validation of outcomes in the new target
population, based on the Phase 3 study data, was recently concluded
and will be presented at the Conference of the European Society for
Medical Oncology (ESMO) which takes place October 20-24, 2023 in
Madrid, Spain.
CEL-SCI is seeking a pathway towards approval of Multikine
throughout the UK. CEL-SCI’s goal is to apply for marketing
authorization in the UK as soon as possible, based on the data
already generated. Just two weeks ago CEL-SCI filed a similar
submission with the European Medicines Agency (EMA).
“We have a comprehensive global regulatory approval strategy,”
stated CEL-SCI’s CEO Geert Kersten. “Having received encouraging
submission guidance from Health Canada, we plan to file for a NOC/C
conditional approval there. This pathway would allow CEL-SCI to
request immediate approval based on the data generated to date, and
any additional studies if needed would be done post-market. With
the European Medicines Agency and the MHRA, we hope to do the same.
We are extremely excited about the results seen in the newly
defined Multikine target population.”
CEL-SCI’s pivotal Phase 3 study tested Multikine in newly
diagnosed locally advanced head and neck cancer patients. The study
demonstrated a nearly 4-year median overall survival benefit for
Multikine treated patients who were treated with surgery and
radiotherapy versus the control group who did not receive
Multikine. The dire need for a new and effective treatment for
newly diagnosed locally advanced primary head and neck cancer is
widely recognized in the medical community.
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 the standard of care, which
involved surgery followed by either radiation or chemoradiation.
Our approach is unique because 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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version on businesswire.com: https://www.businesswire.com/news/home/20231005175200/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
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