CEL-SCI Reaches Full Enrollment in Pivotal Phase 3 Head and Neck Cancer Study
December 11 2017 - 1:30PM
Business Wire
Major Milestone Achieved in World’s Largest
Head and Neck Cancer Phase 3 Study
CEL-SCI Corporation (NYSE American: CVM) announced today
that no further patient enrollment is required in the pivotal Phase
3 head and neck cancer study of its investigational immunotherapy
Multikine* (Leukocyte Interleukin, Injection). The accrual and
treatment phases of this Phase 3 study are complete. All of the 928
enrolled patients in the study are being followed-up as required by
the study protocol.
CEL-SCI recently announced that the study’s Independent Data
Monitoring Committee (IDMC) completed its most recent review of the
data from all 928 patients enrolled in the study, and recommended
continuing the study as there was no evidence of any significant
safety questions.
The primary endpoint of the study, a 10% improvement in overall
survival of the Multikine treatment regimen plus Standard of Care
(SOC) vs. Standard of Care alone, will be determined after a total
of 298 deaths have occurred in these two main comparator arms of
the study and have been recorded in the study database. The last
patient was enrolled in the study in September 2016. Approximately
135 patients were enrolled in the study from 2011 to 2013, about
195 were enrolled in 2014, about 340 in 2015, and about 260 in
2016. The study protocol assumed an overall survival rate of about
55% at 3 years for the SOC treatment group alone.
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 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 U.S., 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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