Blueprint
Exhibit
99.2
NEWS
RELEASE
8229 Boone
Boulevard, Suite 802
Vienna, VA 22182.
USA
Telephone (703)
506-9460
www.cel-sci.com
|
COMPANY
CONTACT:
Gavin de
Windt
CEL-SCI
Corporation
(703)
506-9460
|
CEL-SCI
CORPORATION ISSUES LETTER TO SHAREHOLDERS
Vienna, VA, April 4, 2018 -- CEL-SCI Corporation
(NYSE American: CVM) today
issued a letter to its shareholders.
Dear
Fellow Shareholders,
We have
achieved significant progress towards completing and reporting
results on our Phase 3 head and neck cancer study for our lead
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection). The study is fully enrolled. We are following the study
subjects for outcomes and will be able to analyze all of the data
for safety and efficacy when 298 deaths have occurred in the two
main comparator arms of the study and the corresponding data have
been recorded in the study database. Based on overall survival data
available in the scientific literature for the study’s
patient population, advanced primary head and neck cancer patients,
and the fact that all of the patients in our Phase 3 study were
enrolled between 2011 and September 2016, the time when 298 deaths
will be reached in the combined comparator arms of the study should
be near.
The
primary efficacy endpoint of the study is a 10% improvement in
overall survival of the Multikine treatment regimen plus Standard
of Care (SOC) vs. Standard of Care alone. Late last year, the
study’s Independent Data Monitoring Committee (IDMC)
completed a review of the data from all 928 patients enrolled in
the study and found no evidence of any significant safety questions
and recommended the study continue as constituted. Once completed,
should the study meet its primary efficacy endpoint of 10%
improvement in overall survival, CEL-SCI plans to apply for
regulatory approval in major markets including the United States
and the European Union. Head and neck cancer accounts for about 6%
of all cancers worldwide.
In the
$50 million-plus arbitration suit we filed against the former
clinical research organization (CRO) for our Phase 3 trial, we are
pleased to report that during the past few months, both parties
have filed their closing briefs and subsequently also their
responsive briefs. That only leaves the closing arguments which are
scheduled to be delivered this month, April 2018. This final stage
of the arbitration will take place on two consecutive days, with
one party presenting their closing arguments one day and the other
party presenting the next day. The arbitration suit was filed in
October 2013 by CEL-SCI, seeking at least $50 million from the CRO
that originally ran the Phase 3 head and neck cancer study.
CEL-SCI's arbitration claim alleges (i) breach of contract, (ii)
fraud in the inducement, and (iii) common law fraud. We look
forward to a productive end to the arbitration suit in the near
term.
CEL-SCI’s
clinical development program for our LEAPS (Ligand Epitope Antigen
Presentation System) vaccine platform technology continues to
advance with the support of a $1.5 million grant from the U.S.
National Institutes of Health (NIH) to develop CEL-4000, our
rheumatoid arthritis candidate treatment vaccine, the first product
based on our LEAPS platform. Data from pre-clinical studies
currently being conducted will be used in support of an
Investigational New Drug (IND) application we plan to file with the
FDA for CEL-4000. CEL-SCI was recently issued a patent from the US
Patent and Trademark Office for our LEAPS platform
technology.
In the
near term, we look forward to the completion of our arbitration
suit against the former CRO and we also look forward to receiving
results on both the completion and corresponding top line data on
our Phase 3 head and neck cancer trial.
We
thank you for your continued support of our Company.
Sincerely,
Geert
Kersten
Chief
Executive Officer
About CEL-SCI Corporation
CEL-SCI
is a Phase 3 cancer immunotherapy company. The Phase 3 study is
fully enrolled with 928 patients. 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 (Leukocyte
Interleukin, Injection), 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. CEL-SCI has
received patents for Multikine from the US, Europe, China and
Japan.
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. 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 for the year ended September 30, 2017.
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.