CEL-SCI Corporation (NYSE American: CVM) today issued a
letter to its shareholders.
Dear Fellow Shareholders:
CEL-SCI enters 2018 in a position of strength and hope for the
year ahead. We thank all of our shareholders for supporting our
Company during a difficult 2017. I am pleased to report where we
stand today with the items that have the most significant impact on
our Company’s value:
- Our Phase 3 trial in head and neck
cancer is fully enrolled. All that remains is to monitor patients
and determine if our trial has met its primary endpoint of
improving overall survival of Multikine* (Leukocyte Interleukin,
Injection) treated patients following 298 events in the two main
groups. We continue to believe that boosting a cancer patient’s
immune system before surgery, radiation and chemotherapy makes the
most sense because that is the time when the immune system is
thought to be strongest.
- In October 2013 we filed an arbitration
suit seeking at least $50 million against the clinical research
organization (CRO) that was originally contracted to managed our
phase 3 trial in head and neck cancer patients and which was
subsequently replaced by us. This arbitration finally completed its
testimony phase in early November 2017. We are now working on
post-trial submissions and closing statements to bring this
arbitration to conclusion and finally allow the arbitrator to reach
and issue a final decision.
- With a new $1.5 million grant from the
National Institutes of Health, we are moving our LEAPS rheumatoid
arthritis vaccine forward towards filing an Investigational New
Drug application. Data regarding the vaccine were presented at
numerous scientific conferences throughout 2017.
Full Enrollment Achieved in Phase 3 Head
and Neck Cancer Study for Multikine
We began 2017 with the pivotal Phase 3 trial of our
investigational immunotherapy Multikine on clinical hold with the
U.S. Food and Drug Administration (FDA). Following a thorough
review of the study protocol, its management, and the study data,
the FDA removed the clinical hold in August 2017. When the hold was
imposed on the study at the end of September 2016, 928 patients had
already been accrued to the study. During the clinical hold period
we continued to follow up all enrolled patients per the
protocol.
Very recently, in December 2017, our Phase 3 study’s Independent
Data Monitoring Committee (IDMC) completed its review of the Phase
3 study data. The data from all 928 enrolled patients were provided
to the IDMC by the CRO responsible for data management of this
Phase 3 study. The IDMC saw no evidence of any significant safety
question and recommended continuing the study.
Following the IDMC’s review, we determined that the study is
fully enrolled with 928 patients. When the clinical hold was placed
by the FDA they specified that no additional patients could be
enrolled. The FDA clinical hold therefore did not stall the study’s
progress as we had achieved full enrollment prior to the FDA’s
hold.
We are proud of achieving a major milestone by completing
enrollment in what we believe is the world’s largest Phase 3 study
in advanced primary head and neck cancer. This patient population
and disease indication desperately need a new approach since it has
been over 60 years since the FDA has approved a new drug to treat
advanced primary head and neck cancer. Head and neck cancer
represents about 6% of new cancer patients.
The primary endpoint of the Phase 3 study is a 10% improvement
in overall survival for patients treated with Multikine treatment
regimen plus Standard of Care (SOC) versus patients treated with
Standard of Care alone. Per the study’s protocol, this will be
determined after a total of 298 events (patient deaths) have
occurred in the two main comparator arms of the study and have been
recorded in the study database.
Arbitration suit filed by us against our
former CRO
In October 2013 CEL-SCI filed an arbitration 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. The last witness in the arbitration hearing testified in
November 2017. No further witnesses or testimony are expected. With
that final witness, the testimony phase of the arbitration was
concluded. All that remains at the trial level are closing
statements and post-trial submissions. We look forward to
concluding the arbitration soon and receiving the arbitrator’s
final decision.
Rheumatoid Arthritis Vaccine, Offering New
Treatment Paradigm, Receives $1.5 M NIH Grant
CEL-SCI received a $1.5 million grant from the U.S. National
Institutes of Health (NIH) to develop our potential rheumatoid
arthritis vaccine, CEL-4000. CEL-4000 is the first product
candidate based on our LEAPS (Ligand Epitope Antigen Presentation
System) vaccine platform. The grant provides funding to advance our
rheumatoid arthritis vaccine towards filing an Investigational New
Drug (IND) application. The grant provides funding for developing
GMP manufacturing, and performing IND enabling studies, and
additional mechanism of action studies.
Pre-clinical studies showed that CEL-4000 prevented the
development and lessened the severity of arthritis in animal models
resembling the human disease. Therefore we believe it has the
potential for use as a therapeutic vaccine to treat rheumatoid
arthritis in humans. CEL-4000 data were published in an article in
the July 2017 issue of the scientific journal Vaccine, as well as
presented at several scientific conferences in 2017 including:
- Madridge's International Conference on
Vaccines in Baltimore, Maryland
- 17th Annual World Vaccine Congress in
Washington D.C.
- 2017 Annual Meeting of the American
Association of Immunologists in Washington, D.C.
In addition to rheumatoid arthritis, our patented LEAPS
technology-based vaccine platform may be used as therapeutic
treatments for a variety of different types of autoimmune
conditions. LEAPS vaccines act early on the immune response path
and inhibit the production of disease-promoting inflammatory
cytokines, making these treatment vaccines unique and potentially
effective means of preventing and treating autoimmune diseases.
As we begin 2018, we have completed full enrollment in the
world’s largest clinical trial in head and neck cancer. As we
monitor enrolled patients, we expect that a positive outcome in the
trial would enable us to apply for regulatory approval in head and
neck cancer in dozens of global markets. Our rheumatoid arthritis
vaccine studies are currently being funded by an NIH grant. We
await the final decision in the arbitration suit we filed against
our former CRO in 2013.
We look forward to communicating our progress to our
shareholders throughout 2018. I wish you all a healthy, happy and
prosperous 2018.
Sincerely,
Geert Kersten
Chief Executive Officer
About CEL-SCI Corporation
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
carcinoma.
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 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180103005432/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Apr 2024 to May 2024
Cel Sci (AMEX:CVM)
Historical Stock Chart
From May 2023 to May 2024