CEL-SCI Corporation Issues Letter to Shareholders
June 11 2018 - 9:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today issued a
letter to its shareholders.
Dear Fellow Shareholders,
We expect two very important events for our Company: 1) we
anticipate a final resolution this month of the ongoing arbitration
brought by CEL-SCI against its former contract research
organization (CRO) for its pivotal Phase 3 head and neck cancer
trial and 2) the final read-out of our pivotal Phase 3 head and
neck cancer trial.
Closing arguments in the arbitration suit against the former CRO
were concluded on April 25, 2018, and the arbitrator indicated he
would render his judgement in the matter within 60 days of the
conclusion of closing arguments. Accordingly, by June 24, 2018 we
expect a decision from the arbitrator. CEL-SCI filed the
arbitration suit against its former CRO in October 2013. CEL-SCI's
arbitration claim alleges (i) breach of contract, (ii) fraud in the
inducement, and (iii) common law fraud.
Working with two new CROs for our pivotal Phase 3 head and neck
cancer study, we completed full enrollment of 928 patients in the
largest Phase 3 trial in the world for head and neck cancer. The
last patient was enrolled in the study in September 2016. Based on
overall survival data available in the scientific literature for
the study's patient population we believe that the end of the Phase
3 trial is approaching. We are now following the study subjects per
the Protocol. When 298 events (deaths) have occurred in the two
main comparator arms of the study and the corresponding data have
been recorded in the study database, we will be able to analyze the
data for the primary efficacy and other study endpoints. At this
time, we are unable to provide a more precise indication of when
the Phase 3 study may end because we are unable to predict when the
cancer patients enrolled in the study will die. Once a sufficient
number of events (deaths) have occurred, this will put us in a
position to assess our primary endpoint based on the study’s
overall survival data. 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.
The U.S. Patent Office has recently allowed two new patents for
our LEAPS (Ligand Epitope Antigen Presentation System) vaccine
platform technology for methods for diagnosing, preventing, and
treating disease by generating or modulating the immune response
through the use of specific peptides. The patents allowed are:
- "Method for Inducing an Immune Response
and Formulations Thereof"
- "Method for Inducing an Immune Response
against avian, swine, Spanish, H1N1, H5N9 influenza viruses and
formulations"
Our LEAPS platform technology is currently advancing 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 for the treatment of Rheumatoid
Arthritis (in humans) with the FDA for CEL-4000.
We thank you for your continued support of our Company and we
look forward to informing you as material events occur.
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, in CEL-SCI’s
pivotal Phase 3 study patients who are newly diagnosed with
advanced head and neck cancer are treated first with its lead
investigational immunotherapy Multikine (Leukocyte Interleukin,
Injection), BEFORE they receive 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 currently 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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version on businesswire.com: https://www.businesswire.com/news/home/20180611005340/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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