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VOLUME
03: ISSUE 33
CEL-SCI:
Of Patents and Partners
CEL-SCI
(AMEX:
CVM) has had a wild week and it's only Wednesday. After dropping
from north of $1 last week to a bottom of 67 cents Monday, the shares shot
back to the mid-90-cent range that same day. Currently, the shares are
trading around 95 cents, Wednesday, on growing volume.
Technically,
the shares have retraced 50 percent of this year's low and high perfectly
and look to be gathering steam for another run-up on good volume. While
risk tolerant investors should retain exposure, the swings are tradable
with partial positions. I have had emails from readers who have sold enough
stock on run-ups to now be holding zero cost based stock. An enviable way
to trade this still speculative-albeit ever more interesting -- play.
Renewed investor interest earlier
in the week was likely due to the announcement, Monday, that the Army and
NIH (National Institute of Health) were testing CEL-1000 for various maladies
including SARS, West Nile et al. Investors liked the announcement:
the shares tagged on a quick 25-30 cents and volume rocketed to nearly
10 million shares, Monday. It appears that the buoyant biotech sector also
helps as well as the company's frequent press releases. No doubt investors
are waiting for Multikine peer review studies regarding head and neck cancer
efficacy as well as news of CEL-SCI's progress with the FDA for Phase III
approval. The pieces will, hopefully, fall into place over the next few
weeks and months. Patience is a virtue.
Nailing down Multikine
Attached to this piece is a news
release from CEL-SCI detailing the company's efforts to secure a patent
for the use of of its flagship immunotherapy adjuvant, Multikine, against
the SARS and West Nile viruses. Although relatively new afflictions, there
is little doubt that viral diseases are on the rise, confounding both health
practitioners and authorities, and will require novel treatments.
Demographics will be the driver of
these types of treatments. Since the death rates from SARS and West Nile
among the elderly or those who are immune-challenged can approach 50 percent,
there is both a real need and a potentially huge market.
One thing society is making more
of every minute of every day is more elderly folk. That won't peak until
roughly 2020. CEL-SCI appears to be in the right area to lead or participate
in the next generation of immune-based therapies. Hopefully, if and when
Phase III trials begin, the true efficacy of Multikine will bear out the
company's beliefs:
Dr. Eyal Talor, Senior Vice President
of Research and Manufacturing at CEL-SCI, said, "Multikine has been shown
in humans to have both anti-viral as well as immune-boosting attributes.
We believe that early administration of Multikine, immediately following
diagnosis of SARS, West Nile Virus and other infectious viral diseases,
may help to boost the body's natural immune response, thereby increasing
the infected individual's ability to fight off the disease."
This is powerful stuff. We won't
know the definitive scope of Multikine until data begins to flow from a
Phase III trial and is assessed by third parties. Meanwhile, management
has brought in both distribution and research partners-with attendant grants-and
it looks as though major groups such as the US Army and the National Institute
of Health will undertake a lot of the testing of CEL-SCI's Multikine for
the company's benefit. Terms of the arrangement were not disclosed, but
the deal's high profile adds further credibility to CVM's claims.
It will be a bumpy ride
The shares' volatility at this stage
of CEL-SCI's development has left investors, both new and long-term, breathless.
However, this phenomena is not peculiar to CEL-SCI. Any early stage biotech
company, even one with the excellent prospects, tends to be highly sensitive
to the market's vagaries now and the specter of the FDA's eventual influence.
As
we have noted before, the new regime at the FDA is committed to fast tracking
appropriate drugs and therapies. Again, demographics here are key. As the
population ages rapidly, the demand for faster approvals increases exponentially.
I would submit that the approval process two to five years from now will
make the speed of current and past approval protocols look like molasses
flowing in January.
GLYCOGENESYS
Following on our Trading
Alert Friday last regarding biotech GlycoGenesys (NASDAQ:
GLGS), the company announced Tuesday that it had regained the necessary
listing requirements to trade on the NASDAQ SmallCap market. Early action
Wednesday saw the shares move up to $1.30 and trade well around that price.
Our Alert price was $1.12. We feel that the shares could experience further
strength following the company's presentation, Wednesday, at the BIO 2003
Conference in D.C. Refer to the trading alert link above for details.
Make sure, if you are a high risk
oriented investor, that you consider our trading strategy carefully. Volatility
plays no favorites and takes no prisoners.
Please send us your questions, comments
and feedback here: editor@smallcapnetwork.com
Below is a copy of Cel-Sci's press
release today in its entirety:
CEL-SCI FILES PATENT APPLICATION
FOR DRUG TO TARGET SARS AND WEST NILE VIRUS
Application focuses on older people
who have a significantly increased death rate from both diseases
VIENNA, VA, JUNE 25, 2003
-- CEL-SCI CORPORATION (AMEX:
CVM) has filed a patent application covering the use of its immunotherapy
product Multikine® for the treatment of severe acute respiratory syndrome
(SARS) and West Nile Virus. The application focuses on the use of
Multikine in patients who are immuno-suppressed, such as the elderly.
The death rate in these patients is several times higher than the death
rate in patients below 60 years of age.
The death rate of SARS patients sixty
years and older is thought to be up to 50%. The death rate from West
Nile Virus infection is thought to be between 4 and 47% and is clustered
among newly infected elderly patients.
In general, the human immune system
weakens with age. Individuals sixty years and older are known to
have increased susceptibility to common cold viruses and pneumonia as well
as fungal and bacterial infections and cancer. When older individuals
become infected with SARS or West Nile Virus, their immune system is less
able to mount a robust immune response to keep the disease in check.
Dr. Eyal Talor, Senior Vice President
of Research and Manufacturing at CEL-SCI, said, "Multikine has been shown
in humans to have both anti-viral as well as immune-boosting attributes.
We believe that early administration of Multikine, immediately following
diagnosis of SARS, West Nile Virus and other infectious viral diseases,
may help to boost the body's natural immune response, thereby increasing
the infected individual's ability to fight off the disease."
Multikine, a natural mixture of human
cytokines, has to date been tested in over 190 cancer, HIV and HIV/HPV
infected patients with no severe adverse events related to Multikine administration.
It is under clinical investigation for the treatment of head & neck
cancer and for the treatment of cervical dysplasia caused by the Human
Papilloma Virus (HPV). Multikine is an immune adjuvant with direct
anti-viral and anti-cancer activities, assisting in host immune response
reconstitution.
CEL-SCI Corporation is developing
new immune system based treatments for cancer and infectious diseases.
The Company has operations in Vienna, Virginia and Baltimore, Maryland.
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, 2002. 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.
COMPANY CONTACT:
INVESTOR RELATIONS:
Gavin de Windt
Damian McIntosh
CEL-SCI Corporation
Investor Relations Group
(703) 506-9460
(212) 825-3210
Source: CEL-SCI Corporation
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