CEL-SCI Reports Clinical Hold on Head and Neck Cancer Study
27 September 2016 - 1:03PM
Business Wire
CEL-SCI Corporation (NYSE MKT:CVM) announced today that
it has received verbal notice from the U.S. Food and Drug
Administration (FDA) that its Multikine (Leukocyte Interleukin
Injection) Phase 3 clinical trial in advanced primary head and neck
cancer has been placed on clinical hold. Pursuant to this
communication from FDA, patients currently receiving study
treatments can continue to receive treatment, and patients already
enrolled in the study will continue to be followed. CEL-SCI was
also told to expect a formal letter from the FDA within 30 days and
will work diligently with the FDA to obtain the release of the
clinical hold. The study currently has about 926 patients
enrolled.
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. 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 has been
completed at the University of Maryland. The latter indication is
now in a Phase 1 trial at UCSF. CEL-SCI has issued 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
Corporation'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 have 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 currently in
progress.
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version on businesswire.com: http://www.businesswire.com/news/home/20160926006532/en/
CEL-SCI CorporationGavin de Windt,
703-506-9460www.cel-sci.com
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