CEL-SCI Reports Recent Data Review By the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head & Neck Cancer St...
December 07 2017 - 7:30AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) announced today
that the Independent Data Monitoring Committee (IDMC) for the
Company’s pivotal Phase 3 head and neck cancer study of its
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection) has completed its review of the Phase 3 study data. The
data from all 928 enrolled patients were provided to the IDMC by
the clinical research organization (CRO) responsible for data
management of this Phase 3 study.
The IDMC made the following observation and recommendation:
a) The IDMC saw no evidence of any
significant safety questions.b) The IDMC recommends continuing the
study.
IDMCs are committees commonly used by sponsors of clinical
trials to protect the interests of the patients and the integrity
of the study data in ongoing trials, especially when the trials
involve patients with life threatening diseases, and when, as in
cancer clinical trials, they extend over long periods of time.
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. When it comes
to cancer immunotherapy, CEL-SCI believes it is most logical to
boost the patient’s immune system while it is still intact in order
to have the greatest possible impact on survival. Therefore,
CEL-SCI treats patients who are newly diagnosed with head and neck
cancer with its lead investigational immunotherapy Multikine,
BEFORE they have received surgery, radiation and/or chemotherapy.
This approach is unique. Most other cancer immunotherapies are used
only after conventional therapies have been tried and/or failed.
Head and neck cancer represents about 6% of all cancers. Multikine
has received Orphan Drug designation from the FDA for the treatment
of head and neck cancer patients with advanced squamous cell
carcinoma.
The Company’s LEAPS technology is being developed as a
therapeutic vaccine for rheumatoid arthritis and is supported by
grants from the National Institutes of Health. CEL-SCI has patents
on Multikine from the US, Europe, China, and Japan.
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 and 10-K/A for
the year ended September 30, 2016. 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.
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CEL-SCI CorporationGavin de Windt, (703) 506-9460
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