Attached files
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8-K - CURRENT REPORT - CEL SCI CORP | cvm_8k.htm |
Exhibit 99
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NEWS
RELEASE
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8229
Boone Boulevard, Suite 802
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COMPANY
CONTACT:
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Vienna,
VA 22182. USA
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Gavin
de Windt
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Telephone
(703) 506-9460
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CEL-SCI
Corporation
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www.cel-sci.com
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(703)
506-9460
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CEL-SCI SUBMITS FDA RESPONSE FOR ITS PHASE 3 HEAD AND
NECK CANCER TRIAL
928 patients have been enrolled, treated, and are now being
followed for Study’s Primary Endpoint
Vienna, VA, June 5, 2017 -- 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.
Cel-Sci
Press Release FDA Response 6-5-17