CEL-SCI Corporation Issues Letter to Shareholders
April 04 2018 - 8:00AM
Business Wire
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.
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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