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d*****c
发帖数: 23 | 1 有人hold吗？公司的研发还在继续，Multikine的三期可能快开始了。
我转封CVM头的信。现在股价短期适中。
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CEL-SCI Corporation Releases Letter to Shareholders
VIENNA, VA, July 7, 2009 – The following letter is being released by CEL-
SCI Corporation (NYSE AMEX: CVM) to its shareholders:
Dear Fellow Shareholders:
Recently we have been hearing a great deal about the pandemic caused by the
H1N1 swine flu. You may think to yourself, this is no big deal since it
does not seem that serious and, look what happened to bird flu - it
disappeared. Wrong – on both counts! In this letter I will show you where
in the world, outside of the Far East, we already have a potent reservoir
of bird flu just waiting to “meet” the swine flu. Once one person
infected with a combined bird/swine flu virus gets on a plane, there will be
no way to contain that next stage of the continuing pandemic. CEL-SCI
scientists and their collaborators are in the process of trying to develop a
vaccine/treatment for this eventuality.
Before I get into more details, I want to thank my fellow shareholders for
supporting us during the past 9 months of the financial crisis. The crisis
severely tested us and we have become better at what we do. In the process
we have also defined CEL-SCI to work in three separate business units, all
designed to support each other to make an enormous difference for the world
and create financial success for our shareholders.
The three business units are:
1. Vaccines/treatment: H1N1 (swine) and other influenza viruses,
as well as a vaccine for rheumatoid arthritis.
2. Unique contract manufacturing services using our new
manufacturing facility near Baltimore, MD to generate additional revenue
streams.
3. Our late-stage non-toxic cancer immunotherapy, Multikine,
designed to make the first cancer treatment more successful.
We believe that this combination of assets is fairly unique in the
biotechnology industry and explains why we were one of the few companies
able to raise a substantial amount of money in recent times.
H1N1 (swine) and other influenza viruses:
As reflected by global events over the Fourth of July holiday, our assets
and expertise could prove to be particularly important in battling the H1N1
(swine) flu pandemic. Only last week, Buenos Aires declared a swine flu
health emergency amidst escalating morbidity and mortality in the Southern
Hemisphere. Argentina’s experience in dealing with the winter flu season
shows us how challenging our own flu season will likely be this fall and
winter, even without the virus getting worse. In the United Kingdom, the
country's health secretary said in early July that the U.K. could have more
than 100,000 flu cases a day by the end of August. During the weekend, the
World Health Organization (WHO) convened a high-level meeting in Cancun,
Mexico. At this meeting the WHO’s Director General was underscoring the
unstoppable nature of swine flu and its potential to mutate – “Constant,
random mutation is the survival mechanism of the microbial world. Like all
influenza viruses, H1N1 has the advantage of surprise on its side”. At the
same time, the second and third global cases of Tamiflu-resistant swine flu
were reported. Significantly, the third case was reported in a 16-year-old
girl (Hong Kong) who was Tamiflu resistant even though she had never been
treated with Tamiflu: she was infected with swine flu viruses that already
were resistant to Tamiflu.
While it is not yet clear whether the Hong Kong case is a result of
resortment (gene-swapping), the advent of Tamiflu-resistant strains of swine
flu that have shown the ability to spread is particularly troubling given
the rapidly-evolving bird flu situation in one country where public health
experts are increasingly concerned about resortment – Egypt. On July 1st,
WHO reported that there have been 81 confirmed human cases of H5N1 bird flu
in Egypt, of which one-third (27 cases) have been fatal. As the swine flu
pandemic rages on, there is a growing risk that H1N1 could find abundant
opportunities to swap genes with the bird flu given the prevalence of pigs
in Egypt – a common “breeding ground” for viruses that promotes
resortment. A further-mutated swine flu virus that combines with the bird
flu in Egypt or elsewhere in the world has the potential to be particularly
lethal especially if it is Tamiflu-resistant. Knowing this the Egyptian
government has been trying to cull the pigs in Egypt, but there has been
significant resistance from many groups. History shows that these kinds of
government interventions are never completely successful.
That is precisely why we are aggressively pursuing development of the
therapeutic and preventative vaccine approaches that our scientists have
pioneered. With the world health community perhaps on the verge of losing
its third of four flu drug weapons against swine flu – Tamiflu –
potentially leaving only Relenza (zanamivir) as the sole option for
treatment and prophylaxis, we believe it is critically important to look
beyond the swine flu strain originally found to be circulating. We must
anticipate its evolution and prepare for mutant strains to appear from
remote regions of the globe. Those mutant strains of the virus could
possess virulence and other properties that far exceed those of the current
strains. We believe the therapeutic and longer-term preventative vaccine
approaches we are investigating could address these critical needs. In
developing these vaccines, we recognize, as WHO’s Director General said in
Cancun, “We have the advantages of science, and of rational and rigorous
investigation, on our side.” We are going to continue leveraging these
assets as we try to tackle this persisting and deeply-troubling public
health crisis.
Contract manufacturing services:
We recently completed our $22 million manufacturing facility. During the
next 3 months, it will be validated for clinical supplies and readied for
contract manufacturing. This facility was built to manufacture Multikine
for the Phase III trial and sale thereafter. Due to the unique requirements
for Multikine, we have developed over the last 10 years a cold fill at this
facility which is not available for contract manufacturing anywhere else.
This means that we can fill our Multikine into vials in a completely sterile
manner not only at room temperature, as everyone else does, but also at 4
degrees Centigrade. For Multikine, this is a critical step since long
exposure to room temperature not only “kills” the biological activity of
the investigational product, but may also alter the ratios of the
biologically active components and therefore change Multikine. Similar needs
exist for every other biologic, including stem cell-derived products and
biosimilars. Our 4 degree Centigrade cold aseptic fill will be offered to
the industry as a contract service. I leave you with one simple thought:
how would your life be affected if you did not have a refrigerator or
freezer? We believe that the 4 degree Centigrade cold aseptic fill has the
same kind of impact on the pharmaceutical/biotechnology drug industry.
Multikine cancer therapy:
We believe that the most critical step the company can take is to enter the
pivotal Phase III clinical trial to support marketing applications for
Multikine. In published studies, Multikine has been shown to be non-toxic,
to increase survival by 33%, and to eliminate the tumor in 12% of the
patients after only a 3-week treatment. The recent success of Dendreon with
its prostate cancer vaccine has shown that it is possible to stimulate the
immune system of cancer patients to increase survival. Dendreon went from
about $3 to $27 on that news. The validation of the manufacturing facility
is a critical step to starting this Phase III trial.
Our Phase III trial has been designed to remove many of the common clinical
trial problems. We have identified the most common reasons for Phase III
study failures or failure to receive approval to sell a drug, other than the
drug not working, and they are:
1. Phase III study not reviewed by FDA and not acceptable to FDA:
Our Phase III study was reviewed in detail, and we have made changes based
on FDA’s comments prior to commencement of the Phase III trial.
2. Study too small:
Our study will enroll about 800 patients, a very sizeable number.
3. Clinical endpoint not relevant:
We follow overall survival of the patients, the gold standard. The clinical
endpoint cannot be more relevant.
4. Change in treatment protocol between Phase II and Phase III
without additional studies:
We have made no such changes. Therefore, we expect the Phase II results to
be representative of the results one can expect in the Phase III trial.
5. Insufficient attention to manufacturing issues:
We have validated our manufacturing process and built a dedicated
manufacturing facility for Multikine.
We believe that the success of this study will open cancer therapy to a
whole new way of fighting cancer, one that is not toxic and one that works
with the body, not against the body. We have high confidence that this
study will be successful for the following reasons:
* All clinical indicators support the finding of increased survival in
Phase II.
* The 10% increase in overall survival needed to meet the Phase III
endpoint is substantially smaller than the 33% increase seen in Phase II.
* No toxicity issues have been identified.
* No safety issues have been identified.
* Clear unmet medical need.
* FDA granted Multikine Orphan Drug status in the USA.
Our clinical success would be huge since Multikine would be on course to
become the recommended first-line treatment for head and neck cancer. From
there, we could hopefully prove that Multikine is likely to work against
other solid tumors as well.
Our ultimate goal in development is to provide patients and physicians with
a new and better way of fighting cancer. We believe that the key to doing
so lies in our immune system. Dendreon’s prostate cancer vaccine recently
established that this is possible. Their success is even more impressive
because they focused on late-stage cancer patients. We believe that
Multikine should have an even greater chance of success because we focus on
patients not yet treated for their cancer. Their immune system is still
intact, except in the area of the tumor, and their lymphatics have not yet
been cut, meaning that they can still deliver immune cells from the local
lymph nodes to the tumor.
From here on there is only one thing to do. We will launch the Phase III
study as quickly as possible. Success would be phenomenal, and we
anticipate that it should enable rapid approval around the world.［［他们也
许已经有资金注入，现在已经建好生产multikine基地。三期实验会很快开始；如果三
期开始，我认为这股会小彪一下］］
We thank you for your continued support.
Sincerely,
Sincerely,
Geert Kersten
Chief Executive Officer
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