CEL-SCI Readies Its Multikine Manufacturing Facility for Commercial Scale Production
19 10월 2023 - 9:00PM
Business Wire
Achieves significant milestones toward
commissioning of manufacturing facility in preparation for
Biologics License Application for regulatory approval
submissions
CEL-SCI Corporation (NYSE American: CVM) today reported
that its Multikine* (Leukocyte Interleukin, Injection) cGMP
state-of-the-art dedicated manufacturing facility commissioning is
substantially complete, a significant milestone toward a planned
Biologics License Application (BLA) with several regulatory
agencies for approval of Multikine in the treatment of head and
neck cancer.
Originally constructed and validated to supply Multikine for the
world’s largest global pivotal Phase 3 trial in locally advanced
squamous cell carcinoma of the head and neck, CEL-SCI’s facility
has been expanded and upgraded in preparation for submission of
Multikine for regulatory approval and commercial scale
manufacturing.
In keeping with CEL-SCI Validation Master Plan, industry
standards, International Society for Pharmaceutical Engineering
(ISPE) guidelines, International Conference for Harmonization
(ICH), and in compliance with regulatory guidelines, CEL-SCI is
commissioning and qualifying the facility’s utilities, systems, and
equipment. The facility will be subject to regulatory review prior
to the granting of a commercial manufacturing license and marketing
clearance for Multikine in the treatment of head and neck
cancer.
“Due to the high degree of manufacturing complexity,
company-specific know-how, and trade secrets involved in the
production of Multikine, the commissioning of our facility is a
substantial part of the BLA which we intend to file with regulators
including the U.S., Canada, UK, and Europe. Our team has worked
diligently over the past few years adding complex improvements to
the facility, to get us to where we are today, and we are very
proud of what has been achieved,” stated CEL-SCI’s CEO Geert
Kersten.
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/20231019198044/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
www.cel-sci.com
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