CEL-SCI Corporation Releases Letter to Shareholders
May 18 2012 - 9:00AM
Business Wire
The following letter was provided to shareholders by CEL-SCI
Corporation (NYSE MKT: CVM) for today’s annual shareholder
meeting:
Dear Fellow Shareholders:
Last year, 2011, was an exciting year for us because we were
finally able to start our Phase III clinical trial for our
investigational cancer drug Multikine® (Leukocyte Interleukin,
Injection)*. This trial is the largest head and neck cancer study
ever conducted in the world and is designed to hopefully give us
approval to market Multikine throughout the world.
This trial, which is designed to prove to the most rigorous
standards that Multikine works, was launched in dozens of hospitals
located in eight countries on three continents. All of us at
CEL-SCI are very proud of this major accomplishment. If we are
successful in proving that the addition of Multikine to the current
cancer therapies increases the patients’ overall survival, we would
then expect to submit the Multikine drug dossier to regulatory
agencies around the world for approval.
It has been a long road to this point, but that appears to be
the norm for a “first in a new class” drug such as Multikine. Our
vision for Multikine has always been that, by activating the immune
response against the cancer, it could be a useful addition to the
current treatment options used by cancer patients and doctors – and
that it should add little to no toxicity to the existing treatments
being used. With this vision in mind we selected head and neck
cancer, a hard to treat and devastating disease, as a first target
for Multikine. Head and neck cancer represents a clear unmet
medical need, and there is currently one standard of care for its
treatment worldwide. By adding Multikine to the current standard of
care we hope to improve the overall survival currently achievable
in these patients. As only little progress has been achieved in
these patients in the past 50 years, this would be seen as a major
achievement.
We carefully planned for, designed, and now are executing our
Phase III clinical trial to the highest standard because we
recognize that this is what it takes to succeed. We built a fully
validated manufacturing facility near Baltimore, Maryland, USA, to
ensure that the Multikine used in our Phase III trial would be
consistent from lot to lot. Our study was intentionally designed to
be very large and international in scope to improve our chances
that the study results would be sufficiently robust so that it
would not be required by the regulatory authorities that we conduct
multiple studies to achieve approval of Multikine for commercial
distribution. The international scope of the study will also
increase rate of enrollment in the study so the study may be
completed more rapidly, and allow us to submit applications for
approval in multiple countries around the world. It is our strong
belief that this study will prove that Multikine treatment will
increase the overall survival of head and neck cancer patients.
The following is a brief summary of the key operational
successes in 2011:
- Our Phase III study for Multikine
started in one US cancer center in the final days of 2010. During
2011 we initiated 36 additional hospitals in 8 countries on three
continents. That is a very fast pace for adding clinical sites to
an international study.
- Patients were enrolled in the study on
all three continents (North America, Europe and Asia).
- Our partners Teva Pharmaceuticals
Industries (Israel) and Orient Europharma (Taiwan) enrolled
patients in their respective territories.
- We produced multiple lots of Multikine
in our manufacturing facility near Baltimore, Maryland, USA and
provided drug in sufficient amounts at all clinical sites.
I am constantly being asked how the study is going. As you may
know, I am not allowed to discuss the study results at this early
stage. However, that being said, our confidence may be best
expressed by the decision made to expand the trial into four extra
territories at additional expense and effort, with the help of our
partner Teva in certain areas. We are doing so because we want to
complete the study to prove Multikine’s effectiveness as quickly as
possible and hopefully receive marketing approval from the
regulators.
If we are able to replicate the promising results seen in our
earlier studies and prove that Multikine increases the overall
survival of cancer patients by 10% (the study’s primary end point)
or more, how much value will this create for our shareholders? No
one knows exactly, but it should be significant. By way of example,
in 2011 we witnessed the largest acquisition ever of a company with
products still in clinical development, not yet on the market.
Gilead Sciences bought Pharmasset (Hepatitis C) for about $11
billion in cash. The take home message from this acquisition is
clear. Established pharmaceutical companies are willing to pay very
large amounts of money for products that address both a large
market and represent an unmet medical need. They prefer to wait
until most of the risk has been taken off the table. Multikine
addresses advanced primary (not yet treated) head and neck cancer,
about 5-6% of the world’s cancer cases, clearly a large market.
Advanced primary head and neck cancer also represents a clear unmet
medical need.
The processes of manufacturing of biological substances and
running clinical trials in cancer are extremely complex. We are
able to do both because we have assembled a team of world experts
who share our vision to help cancer patients. We thank you for your
continued support and wish you a very happy, healthy and prosperous
2012.
Sincerely, Geert Kersten Maximilian de
Clara Chief Executive Officer President
* 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 our 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 (Leukocyte Interleukin,
Injection). Further research is required, and early-phase clinical
trial results must be confirmed in the well-controlled, Phase III
clinical trial of this investigational therapy that is currently in
progress.
When used in this report, 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 which 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 SEC
filings, including but not limited to its report on Form 10-K for
the year ended September 30, 2011. 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.
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