Full Press Release Details
form8k801exh999-16.txt
EXH 00 - PR RE STUDY HOLD
Contact: Gavin de Windt
Investor Relations Manager
Email address:gdewindt@cel-sci.com
CEL-SCI REPORTS CLINICAL HOLD ON HEAD AND NECK CANCER STUDY
VIENNA, VA, September 26, 2016 - CEL-SCI Corporation (NYSE MKT: CVM) announced
today that it has received verbal notice from the U.S. Food and Drug
Administration (FDA) that its Multikine (Leukocyte Interleukin Injection) Phase
3 clinical trial in advanced primary head and neck cancer has been placed on
clinical hold. Pursuant to this communication from FDA, patients currently
receiving study treatments can continue to receive treatment, and patients
already enrolled in the study will continue to be followed. CEL-SCI was also
told to expect a formal letter from the FDA within 30 days and will work
diligently with the FDA to obtain the release of the clinical hold. The study
currently has about 926 patients enrolled.
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. Its lead investigational immunotherapy,
Multikine (Leukocyte Interleukin, Injection), is currently being studied in a
pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. If the study endpoint, which
is an improvement in overall survival of the subjects treated with the Multikine
treatment regimen plus the current standard of care (SOC) as compared to
subjects treated with the current SOC only, is satisfied, the study results will
be used to support applications that the Company plans to submit to regulatory
agencies in order to seek commercial marketing approvals for Multikine in major
markets around the world. Additional clinical indications for Multikine that are
being investigated include the treatment of cervical dysplasia in HIV/HPV
co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected
men and women. A Phase 1 trial of the former indication has been completed at
the University of Maryland. The latter indication is now in a Phase 1 trial at
UCSF. CEL-SCI has issued patents on Multikine from the US, Europe, China and
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen
Presentation System) technology for the potential treatment of pandemic
influenza in hospitalized patients and as a potential vaccine for the treatment
of rheumatoid arthritis.
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 Corporation's filings with the
Securities and Exchange Commission, including but not limited to its report on
Form 10-K for the year ended September 30, 2015. 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 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 have 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 (Leukocyte Interleukin, Injection). 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 currently in progress.