CEL-SCI Corporation Issues Letter to Shareholders
22 Novembre 2022 - 3:00PM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today issued a
letter to its shareholders.
Dear CEL-SCI Shareholders:
I wanted to write to update you on our progress. Our story is
following the well-worn path of all successful biotech companies—we
had always hoped our investigational
drug Multikine* (Leukocyte Interleukin Injection) would help
patients, but now we know that it
does. Our 10-year Phase 3 trial showed that Multikine immunotherapy
significantly extended the lives of patients with locally advanced
primary squamous cell carcinoma of the head and neck (“SCCHN”) –
oral cavity/soft palate. This form of cancer is particularly
difficult to treat, and there has been no improvement in first-line
therapies for those who would get surgery as a first treatment in
more than 50 years, despite major efforts, including by large
Pharma.
Current drug therapies for SCCHN from Merck and Bristol Myers
Squibb (BMS) are approved as a last resort for recurrent tumors
after treatments have failed or for patients who are not candidates
for surgery. By contrast, Multikine is given to newly-diagnosed
patients following initial diagnosis — it’s the first of its kind
with substantial survival benefit in a randomized Phase 3 trial in
locally advanced primary SCCHN. The Multikine treated study
population showed the following advantages over control:
- A median overall survival improvement of 46.5
months—nearly four years.
- 62.7% of Multikine patients were alive after five years vs.
48.6% in the control.
- Nearly one out of every six patients had their tumors shrink by more than 30% in just 3
weeks.
- Five patients had their tumors completely
disappear in just 3 weeks.
- Tumor shrinkage/disappearance cut the
death rate by a factor of three.
There are approximately 210,000 patients diagnosed globally each
year who would be eligible for Multikine treatment following
approval, with about 25,000/annually in the U.S. This group
reflects patients who are deemed at “lower-risk-of-recurrence” per
the Guidelines of the National Comprehensive Cancer Network.
Despite the “lower-risk” label, the disease survival rate is only
about a 48% chance of living past five years. Multikine increased
the survival rate to more than 62% at five years. For patients
deemed at “higher-risk-of-recurrence,” Multikine is not suitable
because those patients receive chemotherapy following surgery,
which we think negates Multikine’s biological mechanism of action.
The lower-risk-for-recurrence patients, by contrast, do not receive
chemotherapy.
CEL-SCI’s data compares favorably to other already approved
SCCHN therapies. Merck’s drug Keytruda was approved for recurrent
SCCHN based on a single-arm trial with a 16% tumor response rate—we
showed the same response rate in a randomized controlled trial.
Keytruda did not show a survival improvement—we showed a 29%
survival improvement. BMS’s drug Opdivo was approved based on only
a 2.4-month life extension—we showed a median 46-month improvement
in life extension. Furthermore, Multikine has a much more favorable
toxicity profile than these approved products.
You might ask what is taking so long? For one, our treatment
approach is new – no one has done this before successfully in this
disease, and our data are unprecedented. Giving a treatment before
surgery is called “neoadjuvant,” and this is a completely new
approach for treating SCCHN. None of the currently-approved
immunotherapies for SCCHN are indicated as a neoadjuvant – to be
given first after diagnosis. New discoveries such as ours are
exciting and can provide great benefits to patients and
shareholders, but they inherently take longer to move forward
because they require more discussion and more proof. There is
little precedent we can use to leverage our drug forward, and we
have to prove safety and efficacy from scratch without standing on
the shoulders of those who have come before us. This takes
time.
We also do not have the resources of Merck or BMS, and this
contributes to the timing as well. Simply put, we have a much
smaller team. Nevertheless, I am proud to say that we have
assembled an incredible bullpen of experts. We have brought in
consultants who used to work at FDA, world-class biostatisticians,
and Key Opinion Leaders to help us. Our team is working 24/7 on the
approval process for Multikine in this horrible cancer.
My personal belief in the success of Multikine is evidenced by
the fact that I have not personally sold a single share of CEL-SCI
in the past 20-plus years. In fact, I have repeatedly invested
more. There is a very great need for the benefits that Multikine
has shown it can provide. We are dealing with a devastating cancer.
Tongues are removed at surgery, people’s faces are disfigured,
affecting speech, eating, breathing, and so much more. For decades,
despite much effort, every study in locally advanced primary SCCHN
has failed to show any survival benefit—until this pivotal study
for Multikine. In our study, which is the largest and longest SCCHN
study ever, Multikine added significant overall survival advantages
to patients who received only radiotherapy but not to those who had
chemotherapy added to the treatment. And Multikine did not appear
to add any safety issues over and above those of the normal
standard of care. A highly effective cancer drug that does not
appear to add toxicity is truly
unprecedented.
Our detractors say that our clinical trial results are spurious,
but these folks just don’t understand. The lower-risk analysis was
pre-specified in our protocol before the study even began, so we
did not cherry-pick the data. The survival benefit was driven by
tumor shrinkages and tumor disappearances, which were seen with
greater than 99.9999% certainty. And the reduction in death rate
from having a smaller tumor following Multikine and before surgery
was shown with greater than 99.99% certainty. You can’t argue with
the numbers—these benefits are real and they
are the direct result of Multikine.
I believe that this product needs to be made available to
patients because it can save lives. That is what we are working
towards and for you as a shareholder, whether you hold for profit
or personal reasons, or as many do, for both, that is what matters.
We all have seen the ravages of cancer and we need to do better. We
will do all we can to bring Multikine to those patients who would
get the large survival advantage that we saw in the Phase 3
trial.
Thank you for your continued 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, 2021. 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221122005329/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
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