VIENNA, Va., Sept. 20 /PRNewswire-FirstCall/ -- The following letter is
being released by CEL-SCI CORPORATION (Amex: CVM) to its shareholders:
Dear Fellow Shareholders:
Many of us invest in biotechnology because of its life changing
possibilities and its enormous potential for financial return. We all know
that the development of a biotech drug takes a long time, is difficult and
costs many millions of dollars. Yet most of us are willing to wait for the
potential "home run" on our investment as long as the data looks good.
However, the cyclical and at times completely illogical treatment of
biotechnology stocks by the investment community challenges the commitment
of even the most dedicated of investors.
For this reason we are very pleased to point out that CEL-SCI's share
price has outperformed the vast majority of its small and mid cap
brethrens, albeit with enormous cyclical volatility, over the last few
years. Since high volatility will never be eliminated from biotech stocks
like CEL-SCI, we must learn to use it to our advantage. I recently
purchased more stock in the open market because I believe that the present
price represents a great opportunity.
In the spring of 2003 CEL-SCI's financial health looked rather bleak,
our stock price hit an all time low and few people believed in our ability
to survive, much less rebound. Nevertheless, despite a stock market
environment that has been quite unfriendly to small and medium sized
biotechnology companies like ours, we have managed to put ourselves on good
financial footing and increased our share price by several hundred percent;
and that is after CEL-SCI's stock price pulled back from its substantially
higher level in the spring of 2006. We survived, and indeed improved our
position by persistently and carefully following our plan for building
shareholder value and obeying the following rule. "FOLLOW THE DATA, THE
DATA NEVER LIE."
The data for CEL-SCI's products point to a very positive future for our
company. Furthermore, based upon our most recent survival data and our
cautious and deliberate way of proceeding, we believe that we will continue
to build value for our shareholders. Management's sizable investment in
CEL-SCI gives us added incentive to do so.
We aim to make the first line cancer treatment more successful through
the addition of our cancer drug Multikine(R). Multikine will be a major
breakthrough in therapy for cancer patients if we can confirm the increased
patient survival data from our Phase II clinical studies in the planned
global Phase III clinical study that has already received the go-ahead by
the Canadian authorities. Simplistically, would you rather have a 65 - 70%
chance of survival with our Multikine or a 50% chance of survival without
our Multikine? When we can prove this kind of clinical benefit to patients,
shareholder value creation will need no further explanation.
We believe that the market for Multikine may quickly expand beyond the
original head and neck cancer indication. The product has already been
shown to be very safe, and it is very probable that clinical trials will be
conducted with Multikine to examine its usefulness in treating other
diseases in which the affected patients might benefit by the addition of
Multikine to their overall treatment. Furthermore, the use of Multikine,
especially in cancer, would save the health care system money, most likely
a lot of money, as fewer patients will have recurrence of their cancer, and
thus fewer patients will need to be treated. In short, Multikine could
become a very important addition to current cancer treatments.
In the last 18 months we have achieved a number of very important
milestones for Multikine. We have published the mechanism of action in the
Journal of Clinical Oncology, a highly recognized, leading peer-reviewed
cancer publication. We have been granted an important new patent on
Multikine, and we received a no objection letter (NOL) from the highly
regarded Canadian regulators for our Multikine Global Phase III head and
neck cancer clinical trial. Last, but not least, we presented data at the
"Vaccine Discovery and Commercialization" conference in Philadelphia which
indicate that the addition of Multikine prior to the standard of care
treatment resulted in a 33-40% improvement in the median survival at 3 1/2
years after surgery. Survival is the "gold standard" for testing in cancer.
Our CEL-1000 drug has also received a fair amount of attention. It has
shown protection in animals against a number of diseases such as herpes
virus, viral encephalitis, malaria and leishmania. Based on these data, the
U.S. government became interested in its potential for use against avian
flu. We believe that CEL-1000 may have the best avian flu potential in two
areas, one, as an adjuvant to make vaccines more effective and two, as an
adjunct to other antiviral therapies. Either of these uses holds great
promise for CEL-1000 as a product.
We cannot say that the past years have been without difficulties, far
from it, but we have been able to overcome any obstacles that we have
encountered. We believe that future obstacles will also be dealt with in
the same manner. If developing new medicines for cancer were easy, cancer
would have been defeated long ago; after all, President Nixon declared the
war on cancer 36 years ago. Yet cancer is the second leading cause of death
in the U.S. today and, if the trend continues, it is expected to become the
leading cause of death in the next few years.
Today we continue to believe that our CEL-SCI shares are not fully
valued by the market place, an unhappy occurrence for existing
shareholders, but a great opportunity for new shareholders. This is not an
uncommon phenomenon in biotechnology investing and was seen often during
the early days of Amgen or Genentech, today's leading biotechnology
companies. Now almost everybody wishes that they had been long-term
investors in Amgen or Genentech since these companies turned out to be
great investments. In hindsight the successes of these biotech leaders may
appear to have been easy, but an examination of their early history reveals
that things did not always go their way. Until 2003 Genentech seemed to be
the only one who believed in Avastin, its new blockbuster cancer drug.
These companies succeeded because they were persistent and they followed
the data. We plan to do the same.
What is the value of a non-toxic cancer drug that enhances survival? To
cancer patients it is immeasurable. To investors it is so big that they
want to be invested in the company that owns it. That is why I have
invested so much of my own money in CEL-SCI, with new stock purchases just
a short time ago.
Our Phase II data suggest that we have a cancer compound that may
significantly increase survival in patients with advanced primary head and
neck cancer. Our Phase III trial is meant to prove this survival benefit in
a statistically significant manner to get Multikine approved for sale.
In short, we hope to be able to build significant shareholder value by
conducting our important work in a deliberate and methodical manner and
always following the data. This has worked for us in the past few years and
it should continue to work for us in the future as well. We thank you for
your support.
Sincerely yours,
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, 2005. 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.
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460.
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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