CEL-SCI Corporation Releases Letter to Shareholders
13 12월 2008 - 12:11AM
PR Newswire (US)
VIENNA, Va., Dec. 12 /PRNewswire-FirstCall/ -- The following letter
is being released by CEL-SCI CORPORATION (NYSE Alternext US: CVM)
to its shareholders: Dear Fellow Shareholders: Recently we have had
two pieces of important news for CEL-SCI Corporation and its
shareholders. First, the U.N. World Health Organization's Agency
for Research on Cancer report, in reference to the "cancer burden"
wrote that "the global burden doubled in the last 30 years of the
20th Century, and it is estimated that this will double again
between 2000 and 2020 and nearly triple by 2030". Cancer will soon
become the Number One killer in the world, ahead of heart disease.
Those increases are much greater than many people had expected and
clearly make our non-toxic Multikine cancer product even more
important to develop. Second, we need your help with a legislative
proposal advocated by the Biotechnology Industry Organization (BIO)
which would help CEL-SCI bring Multikine to market faster. Last,
what percentage of people do you think will get cancer and how many
of them will die from it? The answer may shake you (see below). In
this letter I also want to review the general status of our
Multikine cancer drug: 1. In the last few months we have hit major
milestones. We signed a Multikine licensing agreement with Teva
Pharmaceuticals, a multinational pharmaceutical company, which will
participate in and pay for part of our Phase III trial, we took
delivery of our new manufacturing facility in Baltimore (see the
pictures at http://www.cel-sci.com/ and click on Updated Pictures
of Manufacturing Facility), and we extended our existing Multikine
partnership with Orient Europharma (OEP) of Taiwan to cover a
larger territory. OEP, like Teva, will participate in and pay for
part of the Phase III clinical trial. We also presented very
promising results on a newly discovered rheumatoid arthritis
vaccine. 2. Cancer, our main target for Multikine, is quickly
becoming the number one killer, surpassing heart disease. Cancer
treatment is not a discretionary expenditure and therefore
pharmaceutical companies and investors alike are attracted to
cancer therapies. 3. Many pharmaceutical companies are making
cancer research a priority. This is a change from their prior focus
on life style, mass marketed drugs. After the Vioxx debacle and
other issues discovered later, it has become significantly more
difficult to receive FDA approval for life style drugs. Recently
Eli Lilly purchased the cancer company Imclone for $6.5 billion,
Pfizer announced that it would focus on cancer and biologics
(Multikine is a biologic for the treatment of cancer) and Roche is
trying to purchase the half of the cancer company Genentech that it
does not own for about $45 billion. 4. As a late stage Phase III
cancer company focusing on a large unmet medical need, we believe
that CEL-SCI is well positioned to partner Multikine with other
companies and thereby pay for future development costs. 5. The
reason we believe that Multikine is an attractive cancer therapy is
because we have shown very good clinical data: a. 12% of patients
receiving Multikine have no tumor left before the normal treatment
has even started, b. overall the Multikine treated patients have
50% less tumor cells before the normal treatment has even started,
and c. long-term survival improvement was 33%, all without
Multikine induced toxicity. We believe that Multikine is able to
achieve these excellent results for three reasons: a. Multikine is
the first immunotherapy drug to be used before the immune system is
destroyed by radiation and chemotherapy. Up to now other
immunotherapy drugs have been given after radiation and
chemotherapy, a time when the immune system is severely weakened.
b. Multikine is also able to circumvent the tumor's defense
mechanisms by creating a new and different attack through CD-4
cells instead of the usual CD-8 cells which the tumor has learned
to shut down. c. Multikine renders the remaining tumor cells
susceptible to the effect of the follow-on radiation and
chemotherapy, thereby potentially increasing the effectiveness of
these treatments. 6. Only one pivotal Phase III trial is needed to
get to approval from the FDA and if approved, Multikine would
become the first line standard of care in head and neck cancer, a
multi-billion market. Now let me share with you a staggering
statistic. In a June 5, 2007 interview in the Wall Street Journal
Genentech's CEO, Dr. Arthur Levinson, stated that that "42% of
everybody out there is going to get cancer. And half of those 42%
are going to die of cancer." That means that almost every 1 in 2
persons will get cancer. I have devoted my life to finding a new
and better way of treating cancer, but I had no idea that the
number was going to be that big. The effects on patients and their
families from cancer are devastating. We must try to do better!
With that in mind I want to highlight a very recent effort by The
Biotechnology Industry Organization (BIO) to help American
biotechnology companies get through the current financial crisis.
BIO is lobbying Congress to include tax provisions in fiscal
stimulus legislation to help small, capital-intensive companies,
such as CEL-SCI. The name of the proposal is "One Time Refund of
NOLs in Lieu of Other Tax Benefits to Sustain Critical R&D
During Financial Distress". The proposal is not a hand-out. It
calls for Congress to allow small companies to "temporarily elect
to receive a refund of their accumulated net operating losses
(NOLs) at a discounted rate in lieu of claiming qualified research
expenses." The plan, which applies only to tax year 2008, requires
that refunds be reinvested in U.S. - based research. Refund
recipients would permanently forgo the ability to claim all NOLs
involved in the computation of the refund. This plan would really
help CEL-SCI and might allow us to launch our very important Phase
III clinical trial much faster. I ask you to please contact your
Congressperson and Senator to express support for this proposal.
This is very important to everyone's life because, unfortunately, I
do not know of any family that has escaped the devastating effects
of cancer. Congresspersons and Senators listen to you, their
constituents. I have already written to my own representatives.
Please write to your representatives right away and make a personal
difference in the fight against cancer. Please tell them that you
support the "One Time Refund of NOLs in Lieu of Other Tax Benefits
to Sustain Critical R&D During Financial Distress" proposed by
the Biotechnology Industry Organization (BIO). This is a critical
bill and it needs your lobbying to become reality. The internet
address for contacting your Congressperson is:
https://writerep.house.gov/writerep/welcome.shtml The internet
address for contacting your Senators is:
http://www.senate.gov/general/contact_information/senators_cfm.cfm
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, 2007. 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. DATASOURCE: CEL-SCI Corporation CONTACT:
Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460 Web Site:
http://www.cel-sci.com/
Copyright