CEL-SCI Submits FDA Response for Its Phase 3 Head and Neck Cancer Trial
June 05 2017 - 8:00AM
Business Wire
928 patients have been enrolled, treated,
and are now being followed for Study’s Primary Endpoint
CEL-SCI Corporation (NYSE MKT: CVM) today announced that
it has responded to the U.S. Food and Drug Administration’s (FDA)
most recent communication from May 2017 about the clinical hold
imposed on the Company’s Phase 3 head and neck cancer study with
Multikine* (Leukocyte Interleukin, Inj.).
The hold issues addressed in the FDA communication were that the
study’s Investigator Brochure (IB) and the “Dear Investigator”
letter need to be revised. Specific deficiencies and their
locations in each of the documents were identified, and directions
were given as to the specific information that should be included
in the revisions of these documents. CEL-SCI revised the documents
exactly as directed by the FDA. If the FDA finds the revisions made
to the two documents to be satisfactory, CEL-SCI is hopeful that
all of the clinical hold issues have now been addressed, and the
FDA will consider lifting the clinical hold.
As of September 2016, nine hundred twenty-eight (928) head and
neck cancer patients have been enrolled and have completed
treatment in the Phase 3 study. In accordance with the study
protocol, the FDA’s instructions, and subject to the clinical hold,
CEL-SCI continues to follow these patients.
The study endpoint is a 10% increase in overall survival of
patients between the two main comparator groups in favor of the
group receiving the Multikine treatment regimen. The determination
if the study end point is met will occur when there are a total of
298 deaths in those two groups.
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. 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 and that
is currently subject to a clinical hold.
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version on businesswire.com: http://www.businesswire.com/news/home/20170605005413/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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