CEL-SCI Corporation (NYSE American: CVM) today issued a
letter to its shareholders.
Dear Fellow Shareholders:
Happy new year to all of you. As we embark on 2021, I feel it is
important to reach out to you to review information about our
unique investigational cancer immunotherapy Multikine* (Leukocyte
Interleukin, Injection) and to answer questions that may be on your
mind about CEL-SCI. At CEL-SCI we are pursuing an idea which could
fundamentally alter the way we treat cancer. We believe that the
key to improving success in the fight against cancer is to make the
first cancer treatment more successful. In the disease we are
focusing on first, advanced primary head and neck cancer, the
3-year survival rate has not improved in decades, a clear unmet
medical need. We are awaiting the final results of our Phase 3
clinical study which is designed to prove the success of our new
therapy.
Our goal is to increase the survival of cancer patients by using
the power of the immune system before surgery, radiation and
chemotherapy have severely damaged it, first in head and neck
cancer, then in other solid tumors. As far as we know our Multikine
is the only medicine/treatment in advanced testing that can be
given to head and neck cancer patients before surgery because only
3 weeks are available for treatment. Most other cancer drugs
require months of treatment. And, in fact, published Phase 2
studies show that some Multikine treated patients experience
complete tumor elimination in just 3 weeks, before surgery. Those
tumor eliminations were confirmed by pathology.
Another key consideration to be able to give a drug as part of
the first cancer treatment regimen is that it needs to be
non-toxic. That is critical since many of the patients will receive
combined radiation and chemotherapy and the toxicities of those two
treatments combined are so severe that some patients may die from
the treatment alone. If our Multikine added toxicity, we would
likely not be able to use it as a first treatment following
diagnosis.
When we commenced this ambitious drug development program over
30 years ago, we were told that we were wasting our time. The
so-called experts said that cancer immunotherapy would never work
because if the immune system fought cancer, we would not get cancer
in the first place. By now we know that the tumor hides from the
immune system and sabotages the immune system’s ability to kill it.
The key is to help the immune system realize that there is a tumor
and provide it with the necessary tools to overcome the tumor. We
think this is best achieved before surgery, radiation and
chemotherapy, when the immune system is healthy and able to
mobilize its full anti-tumor fighting capacity.
As we started our Phase 3 trial in late 2010 the general
consensus among scientists and Wall Street was still negative
towards cancer immunotherapy, but that attitude started changing a
few years later. Two years into the Phase 3 study we hit a major
roadblock. We had to replace and subsequently file suit
(arbitration) against inVentiv, the multibillion dollar Clinical
Research Organization (CRO) that ran our Phase 3 trial in the early
years for lack of performance and breach of contract. Once we had
sued inVentiv, very unusual things occurred, among them, a
government agency investigation and a clinical hold on our Phase 3
study. This was a very difficult time but, in the end, we won the
arbitration, the government investigation was dropped and the
clinical hold on the Phase 3 study was lifted without any changes
to the study protocol. As far as we know, CEL-SCI’s win against
inVentiv was the first time a drug developer had won such a legal
case against a CRO. The arbitrator even assessed inVentiv for the
entirety of the arbitrator’s fees as a result of inVentiv’s
“scorched earth litigation tactics” during the 4.5-year
arbitration.
While the non-performance by the first CRO was one factor that
prolonged our study, we believe that the other major factor in the
length of the study is a very positive one. To meet the study
endpoint, per the study protocol, we needed to wait for 298 events
(patient deaths) to prove a survival benefit. It took us much
longer than anticipated to reach 298 events. Cancer patients dying
more slowly or not dying is a good thing and is in fact the goal of
our study. A very successful cancer immunotherapy drug called
Yervoy took almost 5 years to complete an overall survival study
instead of the expected 3 years because the drug was effective and
patients in the study were living longer.
We are now at the end of the almost 10-year-long study to prove
this completely novel concept of activating the immune system to
fight cancer before surgery, radiation and chemotherapy. The
extensive database for the study was locked late last year (meaning
it was ready to be analyzed) and experts are now analyzing the data
according to a statistical analysis plan that was agreed to and
finalized before database lock.
CEL-SCI is blinded to the study data and is not involved in this
process. The statistical analysis plan follows the protocol stated
objectives and is designed to meet FDA requirements to define the
clinical benefits that Multikine might provide for these patients.
The analysis looks at multiple parameters to be able to gain the
most information on the possible benefits of using Multikine
immunotherapy before any other treatment in these patients.
We understand that you want to know the results from our long
Phase 3 clinical trial. I get that question all the time. We are
even more eager to learn the results as we await the data with
belief that the results will bring a much needed treatment to
extend the lives of people diagnosed with head and neck cancer.
There is a process to getting the results, and we are not part of
it, so we have no choice but to wait.
Another question that comes up is why so much misinformation is
being spread about CEL-SCI and our Phase 3 study on the internet. I
believe the reason is that we are at the end of a huge Phase 3
clinical trial for a large cancer indication. Biotech stocks
nearing major events often have stock manipulators and short
sellers attacking them. Their goal is to use misinformation to
manipulate the share price down after shorting it.
My point to you regarding CEL-SCI is very simple. Our Phase 3
study has had continuous oversight from its inception. The FDA and
over 20 other regulators have received annual unblinded safety
reports on the Phase 3 study directly from the CRO responsible for
data management. CEL-SCI is blinded to the details in these
reports. In addition, the Independent Data Monitoring Committee
(IDMC), with full unblinded access to all trial data, has been
reviewing the study data about twice a year. They have recommended
“continuing the trial without change” as recently as April 2020. We
must wait for the actual data from the study which is in the
process of being finalized by experts.
I have continuously invested in CEL-SCI believing that we will
succeed with this potentially lifesaving drug. Those around me
believe the same. Since we expect that Multikine will produce
positive results, we are currently expanding the manufacturing
facility and hiring more personnel. It has been a very long journey
with many hard-fought battles, but we are very close to the end. If
we are successful, the benefits to cancer patients will be
great.
We thank you for your support.
Sincerely,
Geert Kersten Chief Executive Officer
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.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. 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, 2020. 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/20210104005207/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-1137
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