VIENNA, Va., Feb. 5 /PRNewswire-FirstCall/ -- The following letter is
being released by CEL-SCI Corporation (Amex: CVM) to its shareholders:
Dear Fellow Shareholders:
We are elated!!! After announcing last year that the head & neck cancer
patients enrolled in our key Phase II clinical trial with our cancer drug
Multikine(R) showed a 33% increase in overall survival 3.5 years after
surgery, we now have great news again. In January of 2007 we received the
go- ahead from the U.S. Food and Drug Administration (FDA) to commence our
Phase III clinical trial with Multikine in patients with advanced primary
head & neck cancer. Very few drugs ever make it to Phase III clinical
testing. Our success is even more incredible because Multikine is a "first
in a new class of anti-cancer drugs".
We can still remember the long list of objections that potential
investors threw at us in the past. This list has now become very short. The
only remaining objection to our Multikine in some parts of the investment
community is the fact that Multikine is an immunotherapy treatment.
Immunotherapy, while ultimately expected to be very successful in the
treatment of cancer, has not been successful in studies conducted by other
companies so far. When we mentioned this issue to an oncologist friend of
ours he responded, "But that should not be an issue for Multikine because
you have the data to show that your drug works." He is right, but we still
have to go out of our way to explain why Multikine works when other
immunotherapy drugs have not delivered the expected results.
1) As you know our cancer drug Multikine is a defined and consistent
mixture of human cytokines, substances that coordinate an immune
response. Cytokines as a therapy have been very successful when used in
a situation where there is a clear and simple cause and effect
relationship, such as in the case of Amgen's multi-billion dollar drug,
EPO. If you need more red blood cells, you take EPO and the problem is
"fixed". However, in the treatment of cancer using the single cytokine
approach has not worked well because there is no single cause and
effect. You need a comprehensive anti-tumor immune response to be
successful in the fight against cancer. Our Multikine, as we have
published in the "Journal of Clinical Oncology", empowers the patient's
own immune system to mount a comprehensive and effective anti-tumor
immune response.
2) Historical cancer drug development placed the emphasis on developing
drugs for patients who have failed prior therapy. This same thought
pattern was extended to immunotherapy and immunotherapy was given to
late-stage cancer patients. We now know that this makes no sense -- and
in fact, it is starting to make no sense to many oncologists with whom
we have consulted. Why would one want to try to stimulate the immune
system after it has been ravaged by surgery, radiation and
chemotherapy? There is not much left to be stimulated. We give our
Multikine to cancer patients with advanced tumors that have not yet
been treated because they still have an immune system that can be
stimulated and is able to respond!
3) You may be the best at your job, but you will most likely fail if you
are tasked with everybody else's job which you know little to nothing
about. That is what was requested of immunotherapy by others until now.
It has been asked to clean up the "mess" of all prior failed cancer
therapies pretty much on its own. No wonder it did not succeed!
We give our Multikine to cancer patients in supra-physiological doses,
the way the body does, we give it to patients who have not yet been treated
and still have an intact immune system that can be stimulated, and we give
it as an adjunct (enhancement) to the existing first-line cancer therapy
for advanced primary head & neck cancer patients.
The primary goal of Multikine is to "clean" the tumor margins and to
kill the tumor cells that have migrated to the local lymph nodes. This is
crucial because the tumor cells around the tumor and those in the local
lymph nodes are the primary reason for recurrence in these patients. By
eliminating these tumor cells, we can reduce recurrence of the tumor and
hopefully increase the overall survival of these patients in a meaningful
way.
Multikine does other things as well. All of them can be viewed as
wonderful additional bonuses. Multikine has been shown to be non-toxic,
eliminate the tumor in 12% of the patients after only a 3 week treatment,
on average reduce the number of tumor cells by about 50% before the
scheduled surgery even begins, and enhance the likely effectiveness of the
radiation/chemotherapy treatment given after surgery (Laryngoscope. 2003
Dec; 113(12): 2206-17).
Now that we have FDA go-ahead for our Phase III study with Multikine,
we have a clear path to approval. We were told that we will only need one
clinical trial, as long as the data is robust enough. The Phase III study
essentially is a comparison between the current standard of care for
advanced primary head & neck cancer patients (surgery plus radiation or
concurrent radiation and chemotherapy) on the one hand and our Multikine
for 3 weeks prior to the standard of care on the other hand. This global
study will enroll about 800 patients. To be successful, the group of
patients receiving Multikine plus the standard of care treatment will need
to show a 10% increase in overall survival when compared to the group of
patients receiving standard of care treatment alone.
Historically about 66% of Phase III studies are successful. Of the
failure rate of about 34%, about 1/3 can be attributed to serious safety
issues. Since we have not seen any serious safety issues with Multikine, we
presume that we will not run afoul of that problem and that therefore our
chance of success in the Multikine Phase III should be about 78%. In
addition, we have built several "risk mitigation factors" into our Phase
III study that we hope will give us an even greater chance of success:
1) The Phase III study will use the same Multikine treatment regimen as
did the key Phase II study which showed a great increase in overall
survival.
2) We have powered the study to show an increase in overall survival which
is much less than the one we already observed in our Phase II study.
3) With the help of BioProperties, Inc, a real estate developer
specializing in the construction of biotechnology facilities, we are
building our own Multikine manufacturing facility which will supply the
drug for both the Phase III clinical trial and future sales. Since
manufacturing control is essential to our type of drug (a Biologic),
this approach removes a great deal of risk from the regulatory approval
process.
I hope that by now you understand that we really are at a point of
inflection and that we are developing Multikine in a well-thought-out and
methodical manner. The next question is, "How big is the market?"
Head & neck cancer accounts for about 5-6 % of all cancers, which
translates to about 500,000 cases world-wide annually. Since our Phase III
study is a comparison between the standard of care for first-line therapy
on the one hand and Multikine plus standard of care on the other hand, a
win for Multikine would mean that we would establish a new first-line
standard of care -- one that would require the use of Multikine in addition
to the current standard of care.
In theory, having a drug that is first-line standard of care should
translate into every patient receiving the drug. To be more realistic, let
us assume a 20% market penetration for Multikine, a very low level for a
first- line treatment of a serious life-threatening disease -- such as head
& neck cancer. This would still results in sales of about $2.5 billion
annually, assuming a sales price of $25,000 for the treatment, which is
much less than the cost of many of the new cancer drugs and/or treatments.
In other words, a first-line indication is very significant to patients and
investors alike.
We believe that Multikine is a drug that will change the way we
currently treat cancer.
We will continue to work hard for the success of this new and promising
anti-cancer drug. We thank you for your support.
Sincerely,
Geert Kersten
Chief Executive Officer
When used in this report, the words "intends," "believes,"
"anticipated" 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, 2006. 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.
SOURCE CEL-SCI Corporation
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Related links:
http://www.cel-sci.com
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
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