Full Press Release Details
form8k801ex991dec-17.txt
8229 Boone Boulevard, Suite 802 COMPANY CONTACT:
Vienna, VA 22182. placecountry-regionUSA Gavin de Windt
Telephone (703) 506-9460 CEL-SCI Corporation
www.cel-sci.com (703) 506-9460
CEL-SCI REPORTS RECENT DATA REVIEW BY THE INDEPENDENT DATA MONITORING
COMMITTEE FOR ITS PIVOTAL PHASE 3 HEAD AND NECK CANCER STUDY
VIENNA, VA, December 7, 2017 -- 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 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
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