CEL-SCI’S Multikine Reduced 5-year Death Rate From 54% to 22% in Phase 3 Study Patients Who Were Early Tumor Responders Prior to Any Standard of Care Treatment
17 Octobre 2022 - 2:50PM
Business Wire
- 5 patients had no tumor left following a 3-week treatment of
CEL-SCI’s investigational drug Multikine
- Images clearly show tumors in the patients’ oral cavity
prior to treatment with Multikine and the disappearance of these
tumors before any subsequent standard-of-care treatment, confirmed
at surgery
- There were also partial responses of greater than 30% tumor
burden reduction resulting from the Multikine treatment prior to
subsequent standard of care treatment
CEL-SCI Corporation (NYSE American: CVM) today announced
the availability to the public of an oral presentation delivered by
Dr. Philip Lavin of groundbreaking tumor response and increased
overall survival in head and neck cancer. This presentation
includes data presented at the European Society for Medical
Oncology (ESMO) Annual Congress on September 10, 2022 in Paris,
France. The ESMO poster presentation was titled “Early response to
Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy
extends overall survival (OS) in locally advanced primary squamous
cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS
Study (Clinicaltrials.gov NCT01265849).”
The summary of the most recent data presented from this Phase 3
clinical trial is that a 3-week administration of CEL-SCI’s
investigational Multikine* (LI) treatment achieved groundbreaking
tumor response and increased overall survival in treatment naïve
locally advanced primary head and neck cancer patients who are
scheduled to receive surgery and radiotherapy as their indicated
treatment.
The study had 45 early tumor responses, including 5 complete and
40 partial responses; all were early tumor responses in that they
followed a three-week Multikine treatment, were observed at surgery
and occurred before radiotherapy. Early tumor response to Multikine
treatment was both prognostic and predictive of overall survival.
The Multikine tumor response was differentiating in that it was
observed within a week after completion of the fixed 3-week
Multikine treatment. The degree of response had a significant
impact on subsequent survival, which qualifies Multikine early
tumor response as a surrogate marker.
CEL-SCI strongly recommends that readers listen to the oral
presentation at
https://www.vumedi.com/video/esmo-2022-on-the-it-matters-study-early-response-to-leukocyte-interleukin-injection-io-extends-os-in/.
Dr. Lavin is a well-known biostatistician with a long history of
supporting clinical trials for product registrations,
reimbursements, and public health advancement. He has served on the
faculty of Harvard Medical School at the Harvard School of Public
Health for over 25 years and has been in the oncology field since
1974. Dr. Lavin also advised the FDA from 1983 through 2015 on
product approvals and public policy matters as a Special Government
Employee.
CEL-SCI’s 928-patient Phase 3 IT-MATTERS study was designed to
determine if Multikine provided survival and other clinical
benefits to patients suffering from locally advanced primary
squamous cell carcinoma of the head and neck (SCCHN), oral cavity
and soft-palate. Multikine is a mixture of naturally occurring
cytokines that regulate the immune system. It is the first
investigational cancer immunotherapy being developed as a
first-line neo-adjuvant treatment to be provided to previously
untreated locally advanced disease SCCHN patients before they
receive the current standard of care (SOC), which is either surgery
plus radiotherapy or surgery plus radio-chemotherapy. IT-MATTERS
was conducted in 23 countries. CEL-SCI is preparing to submit a
Biologics License Application (BLA) for marketing approval with the
U.S. Food and Drug Administration (FDA) for Multikine.
The presentation available at the LINK includes the
following:
- 5 patients were complete responders, with surgical
confirmation of clearing all signs of cancer in the oral cavity,
and 40 patients were partial responders to Multikine after 3 weeks
of Multikine treatment, prior to any SOC treatment. Complete early
tumor responses have not ever been reported in the scientific
literature for locally advanced primary head and neck cancer
according to medical experts.
The presentation delivered by Dr. Lavin included images of two
patients who had a complete early response to treatment with
Multikine within 5 weeks and prior to the standard of care surgery
and radiotherapy and anonymized patient profiles for all the 5
complete responders. Images clearly show tumors in the patients’
oral cavity prior to treatment with Multikine and the disappearance
of these tumors 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 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 unique. 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. CEL-SCI believes that this Phase 3 study is the
largest Phase 3 study in the world for the treatment of locally
advanced primary head and neck cancer.
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 was started in early 2011 and was fully
enrolled with 928 patients in September 2016. To test for an
overall survival benefit, the study required CEL-SCI to wait until
at least 298 (deaths) events had occurred among the two main
comparator groups.
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, 2021. 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, and
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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