CEL-SCI Releases Video Detailing Recent Phase 3 Findings & its Plans to Seek Immediate Regulatory Approvals
24 10월 2023 - 9:00PM
Business Wire
View the video:
https://youtu.be/23WqSM9gI40
CEL-SCI Corporation (NYSE American: CVM) today released a
video presentation in which the Company’s CEO, Geert Kersten,
shares the most recent data presented at the European Society for
Medical Oncology (ESMO) Congress and the data’s impact on
propelling the Company’s immunotherapy drug Multikine* (Leukocyte
Interleukin, Injection) toward regulatory approval for the
treatment of newly diagnosed, advanced squamous cell carcinoma of
the head and neck (SCCHN). Mr. Kersten carefully explains how it is
that patients in the target group who were treated with Multikine
had a 5-year survival rate of 73% as compared to only 45% for those
who did not receive Multikine, cutting the risk of death by half.
He goes on to present CEL-SCI’s regulatory submissions plan and
timelines based on these compelling findings for a patient
population that has not had a new treatment approved in in the U.S.
in many decades.
Summary of Multikine Results in the Target
Population:
- 73% survival for Multikine vs 45% in the control at 5
years
- 28% absolute survival benefit
- Statistically significant p=.0015 and hazard ratio = 0.35
- Tumor reduction rate >13% and tumor downstaging >35%
- No safety signals or toxicities vs standard of care
- Target population of an estimated 145,000 patients (global,
annual) who present with:
- No nodal involvement and no extracapsular spread
- Low PD-L1 tumor expression (different from high PD-L1 targeted
by checkpoint inhibitors)
- Physicians routinely assess these features at baseline; no
extra tests needed
- These features make it easy to write a label for the approval
of Multikine, which is essential for drug approval
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 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 called neo-adjuvant. 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.
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. CEL-SCI has completed a 928 patient Phase 3 clinical trial
in locally advanced primary head and neck cancer patients.
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)
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