Cel Sci (AMEX:CVM)
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5 Years : From Sep 2012 to Sep 2017
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
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.
Maximilian de Clara
Chief Executive Officer
* 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.