The following letter is being released by CEL-SCI Corporation
(NYSE MKT: CVM) to its shareholders:
Dear Fellow Shareholders:
As CEL-SCI shareholders most of you have been following the
progress in our Phase 3 head and neck cancer trial, the largest of
its kind in the world. We are proud of what we have achieved in
2015. Before summarizing our accomplishments during the year, I
want to first thank each of you for choosing to support us in an
enormous and ambitious undertaking. We believe that we can bring
the promise of immunotherapy to treating newly diagnosed cancer
patients when they can benefit from it most, before their immune
systems are compromised by the existing cancer standard of care
treatments.
For decades most cancers have been treated with the standard of
care treatments which typically include surgery, radiation and/or
chemotherapy. Now there is talk that immunotherapy represents “the
future of cancer treatments.” We were fervent advocates of cancer
immunotherapy when few believed it would be useful. We are now
investigating in our global Phase 3 clinical study what we believe
is the logical next step in immunotherapy development. Based on the
results of our Phase 2 studies we believe that immunotherapy should
be administered as an initial therapy before a patient’s immune
system has been debilitated by surgery, radiation and chemotherapy.
Data from our Phase 2 studies demonstrated that when Multikine* was
administered for only 3 weeks immediately after diagnosis, the
treatment reduced and in some cases eliminated all signs of a tumor
before surgery, radiation and/or chemotherapy for head and neck
cancer patients were administered.
CEL-SCI is the first, and to our knowledge the only company, to
advance an investigational cancer immunotherapy into Phase 3
studies where it is actually administered as a first-line treatment
immediately after diagnosis in the three week window before any
standard of care treatments. Most other cancer immunotherapy
treatment regimens must be administered over longer periods of time
and cannot be given in the brief three week period before the
current standard of care (surgery and/or radiation and
chemotherapy) must be administered.
Other investigational cancer treatments and immunotherapies are
usually tested as a last resort on patients who have already
undergone and failed standard of care treatments. This is done so
as not to delay the treatment of patients with the current standard
of care. Also, if a therapy which is used as a last resort shows
some efficacy, the primary endpoint for the clinical trial for that
drug will be reached in a fairly short period. That is because
patients in the end-stage of disease have a shorter life
expectancy.
Our path to regulatory approval is longer than it would be if
the patients in our Phase 3 trial had end stage disease. The reason
for this is that the overall survival rate of our patients (the
primary endpoint of our study) cannot be calculated until a certain
number of patients have died. Since the patients in our Phase 3
trial are newly diagnosed cancer patients, they generally live
longer than patients who have failed existing therapies and are in
the end stage of disease. Yet the benefits to patients and rewards
to shareholders will far outweigh the longer time lines if we are
proven to be right. We hope that by administering Multikine prior
to standard of care therapies we can extend the survival of head
and neck and possibly other cancer patients.
If our study is successful we will have reduced the number of
cancer recurrences and increased the overall survival of the
patients who were treated with the Multikine regimen. From head and
neck cancer, already a large market, we can then potentially
develop Multikine for many other solid tumors. Our hope is that
someday Multikine will be administered as the first treatment right
after initial cancer diagnosis for many different types of
cancers.
We chose to attack head and neck cancer first because it is a
large unmet medical need. It represents approximately 6% of all
cancer cases worldwide, about 650,000 new cases per year. It was
about half a century ago when the last new therapy was approved by
the FDA for the treatment of advanced primary (not yet treated)
head and neck cancer, the same patient population that is being
treated in our global Phase 3 study. We are conducting this study
because we believe that our investigational immunotherapy should
result in improving the clinical outcome and provide a new and
better treatment option for these patients.
Our Phase 3 study is currently being conducted in 24 countries,
including the U.S., with 668 patients enrolled at the end of
December 2015. We have invested about $100 million dollars in the
manufacturing of Multikine and have built a full scale
manufacturing facility in Maryland. This facility is a key
component in the FDA approval process for a biological product,
such as Multikine, at the time a Biological Product License
Application (BLA) is submitted. We are very proud of our highly
regarded research partners including the National Institutes of
Health (NIH), the National Institute of Allergy and Infectious
Diseases (NIAID) and the U.S. Navy. Our science is strong and has
been published in leading peer reviewed scientific journals. We
have also received multiple patents for Multikine from the
respective patent offices in the U.S., Europe, Japan and China,
including an additional patent in late 2015 from the European
patent office.
We are very proud of all we have accomplished. We are honored to
have you, our shareholders, share this ambitious vision and journey
with us.
In 2015 we:
- Raised approximately $27.5 million to
finance our expanding Phase 3 trial
- Added 7 countries to our Phase 3
study
- Enrolled 340 patients in the Phase 3
study
- Increased enrollment by 75% over 2014
enrollment
- Exceeded study enrollment of all 4
prior years combined
- Received an additional $2 million in
non-dilutive funding for our Phase 3 trial from our clinical
research organization (CRO) Ergomed, resulting in a total
investment of $12 million from Ergomed in the trial
- Expanded our Phase 1 study of Multikine
in the treatment of anal warts in HIV/HPV co-infected patients by
adding another clinical site and a world renowned key opinion
leader in the field as a Principal Investigator
- Granted additional support from the NIH
for our LEAPS rheumatoid arthritis vaccine
- Fortified our $50 million arbitration
suit against the former CRO whom we dismissed in 2013 by securing
$5 million in non-dilutive funding for litigation expenses
Phase 3 Head & Neck Cancer
Trial
Numerous factors indicate that our Phase 3 trial is proceeding
quite well. We are now enrolling patients at a rate of more than
one per day. This is a brisk enrollment rate that many companies
wish they could achieve. We believe that doctors would not enroll
new patients into the study unless they believed that their
patients were benefiting from the Multikine treatment regimen.
In October 2015 Ergomed, the new CRO managing our Phase 3 trial,
increased its investment into the Phase 3 trial from $10 million to
$12 million. We do not think Ergomed would increase its investment
in Multikine unless they too believed that Multikine could be
successful. Ergomed is risking its own money in this trial, as they
will only receive their money back if Multikine is licensed or
approved. With 668 patients already enrolled, we expect to complete
the currently planned enrollment goal of 880 patients in 2016.
Phase 1 Anal Warts Study in HIV/HPV
Patients
Multikine is an immune therapy that has the potential to help
the body fight not just head and neck cancer but other diseases
too, potentially even viruses. We believe the immune system is a
key factor in how the body fights anal warts in HIV/HPV co-infected
men and women. Our ongoing Phase 1 study in this indication is
being conducted under a Cooperative Research and Development
Agreement (CRADA) with the U.S. Navy at the San Diego Naval Medical
Center. Ergomed has invested $6 million in co-development
agreements to develop Multikine as a treatment for HIV/HPV
co-infected patients, in addition to the $12 million committed to
the head and neck cancer program. In July 2015, we announced
expansion of this clinical trial with the addition of the
University of California, San Francisco (UCSF) as a second clinical
site. Dr. Joel Palefsky, a world renowned key opinion leader in the
field has joined the study as the Principal Investigator at this
site. We look forward to announcing data from this Phase 1 trial in
2016.
LEAPS Preclinical
Program
The current focus for the LEAPS technology is to develop a
vaccine for rheumatoid arthritis. This program has produced good
results. The LEAPS rheumatoid arthritis vaccine has been shown to
prevent the development and lessen the severity of rheumatoid
arthritis in preclinical studies. In recognition of these results
the program has received a $225,000 SBIR grant from the NIH’s
National Institute of Allergy and Musculoskeletal Skin Diseases
(NIAMS) and was selected by the NIH as a recipient of a new
technology commercialization program.
$50 Million Arbitration
Suit
We believe that the current success with enrollment in our Phase
3 trial further validates the claims in our arbitration suit filed
against the CRO that was previously running that same Phase 3
trial. The final hearing (“trial”) date is currently being
scheduled. Our position has been dramatically strengthened by
accepting a $5 million litigation funding offer from Lake Whillans,
a firm that specializes in litigation funding. This means our
arbitration is now fully funded and will cost us nothing going
forward. Lake Whillans, an expert in the field, conducted extensive
due diligence on our case prior to extending the non-dilutive $5
million offer to us. They will only be repaid if we win the
arbitration, by retaining a percentage of the proceeds.
In Summary
In the year ahead we anticipate a series of positive
developments in our Phase 3 trial. Aside from the Phase 3 trial, a
near term upcoming event is our arbitration hearing. Should we win
that hearing, and we believe we have a very strong case, then our
balance sheet will be significantly fortified to support our Phase
3 head and neck cancer study. Other Multikine clinical trials and
LEAPS research could be expanded as well. We look forward to a
strong and positive year for the Company in 2016.
Sincerely,
Geert Kersten Maximilian
de Clara Chief Executive Officer President
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160108005080/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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