CEL-SCI Submits Response to FDA in Connection with Partial Clinical Hold on Phase 3 Clinical Trial
November 21 2016 - 8:30AM
Business Wire
CEL-SCI Corporation (NYSE MKT:CVM) announced today that
it has submitted its response to the U.S. Food and Drug
Administration (FDA) regarding the previously announced partial
clinical hold of CEL-SCI’s Phase 3 clinical trial of its
investigational drug Multikine* (Leukocyte Interleukin, Injection)
in patients with squamous cell carcinoma of the head and neck.
About CEL-SCI Corporation
CEL-SCI's work is focused on finding the best way to activate
the immune system to fight cancer and infectious diseases. Its lead
investigational immunotherapy, Multikine (Leukocyte Interleukin,
Injection), is currently being studied in a pivotal Phase 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. Subject to the
partial clinical hold, the study was designed with the objective
that, if the study endpoint, which is an improvement in overall
survival of the subjects treated with the Multikine treatment
regimen plus the current standard of care (SOC) as compared to
subjects treated with the current SOC only, is satisfied, the study
results will be used to support applications that the Company plans
to submit to regulatory agencies in order to seek commercial
marketing approvals for Multikine in major markets around the
world. Additional clinical indications for Multikine that are being
investigated include the treatment of cervical dysplasia in HIV/HPV
co-infected women, and the treatment of peri-anal warts in HIV/HPV
co-infected men and women. A Phase 1 trial of the former indication
(treatment of cervical dysplasia in HIV/HPV co-infected women) has
been completed at the University of Maryland. The latter indication
(treatment of peri-anal warts in HIV/HPV co-infected men and women)
is being studied in a Phase 1 trial at the University of
California, San Francisco. CEL-SCI has patents on Multikine from
the US, Europe, China, and Japan.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand
Epitope Antigen Presentation System) technology for the potential
treatment of pandemic influenza in hospitalized patients and as a
potential vaccine for the treatment of rheumatoid arthritis.
The Company has operations in Vienna, Virginia, and in/near
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.
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, 2015. 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. Moreover, no definitive conclusions can be drawn from the
early-phase, clinical-trials data involving the investigational
therapy Multikine. Further research is required, and early-phase
clinical trial results must be confirmed in the Phase 3 clinical
trial of this investigational therapy that is in progress and that
is currently subject to a clinical hold on enrollment of additional
new patients.
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version on businesswire.com: http://www.businesswire.com/news/home/20161121005315/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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