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VOLUME
06: ISSUE 17
CEL-SCI
Rockets Higher.
Pre-opening,
Tuesday, biotech CEL-SCI (AMEX:
CVM) traded up to 92 cents. We Alerted
the readership a scant two weeks ago when the shares were idling at 52-cents.
At this writing the shares are trading strongly at 84-85 cents on significant
volume--a rise of over 60 percent since February 10th.
What to do now? Depends on whether
you're a trader or an investor.
The Company also announced today
(release below) the issuance of another significant US patent regarding
its LEAPS (Ligand Epitope Antigen Presentation System) technology platform
for Autoimmune Conditions and Allergies. A discussion of this announcement
follows our technical picture.
There
is little doubt that the shares of CVM have had an excellent early run.
We believe that there is much more to come for CEL-SCI shares. What
to do now depends on your perspective. As we have stated, the 83-85-cent
level represents a technical resistance level. Traders might want to lighten
up a tad and wait for either a 3/8 or 5/8 pullback as shown on the chart
to fill in positions, but should maintain a decent core holding. Long-term
investors should likely hold here and both groups should buy on dips should
they occur. We see good upside potential for the shares, but we'd also
like to see a sustained move above current levels at which time we will
reassess our targets.
Given the volatility of these shares,
as with most small caps, long-term investors--whether adding to or initiating
a position--should always employ a physical or mental stop loss to protect
capital/profits.
More and Better.
The newly issued patent announced
today addresses the pretreatment and early therapy of Experimental
Autoimmune Myocarditis with a compound developed by CEL-SCI resulted in
significant reduction in heart enlargement and disease associated histopathological
changes in mice. The detailed discussion of this significant development
is in the release and I would direct you to give it a careful read,
but the salient point is that:
"These findings could potentially
lead to the development of a treatment for autoimmune myocarditis, a life
threatening heart disease, which is characterized by an enlarged and weakened
heart. Myocarditis is a precursor to dilated cardiomyopathy, a condition
leading to a form of chronic heart failure (CHF) characterized by an inflamed
heart. End stage CHF requires a heart transplant or death ensues."
It is apparent that news and developments
are increasing the visibility of CEL-SCI as evidenced by the both the rising
daily volumes and increased share price. As we have noted, the discounted
market cap of CVM when compared to a number of biotech peers should-- and
may well already --be in the process of coming into line as investors weigh
the commercial potential of the diverse and unique product mix of the company.
CVM's addressing of some of society's
most devastating diseases with novel immunology-based therapies appears
to be gaining the attention of investors as it moves closer to Phase 3
trials, increases its patents and continues its robust R&D.
The potential for CVM's technologies
to use the immune system as a disease fighter represents a new therapeutic
direction from the standard toxic, end-of-life, chronic disease management
drugs/therapies of the Big Pharma companies.
From the release:
Therefore, L.E.A.P.S. is thought
to be a delivery vehicle that directs or controls the immune response to
the desired outcome. This ability to preferentially direct the immune system
is a major breakthrough. Any diseases for which antigenic epitope sequences
have been identified, such as infectious diseases, cancer, autoimmune diseases,
allergic asthma and allergy, are potential candidates for this technology.
Those investors who wish to participate
in this new generation of drugs/therapies would, we believe, be well served
in the long-term by including CEL-SCI within the smallcap biotech section
of a portfolio.
PRESS RELEASE
CEL-SCI Receives U.S. Patent for
Use of L.E.A.P.S(TM) Technology for Autoimmune Conditions and Allergies
Feb 28, 2006 10:28:00
AM
VIENNA, Va., Feb. 28
/PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM) has been issued
a U.S. patent covering its L.E.A.P.S.(TM) peptide vaccine technology in
the areas of autoimmunity and allergies. The new patent, U.S. Patent No.
6,995,237, is titled, "Preparation and composition of peptides useful for
treatment of autoimmune and transplant related graft versus host conditions."
The L.E.A.P.S. technology has also produced the patented CEL-1000 drug,
which induced protection in animals against viruses and parasites and is
being tested by the National Institute of Allergy and Infectious Diseases
against the avian flu virus.
This new patent builds
on work by CEL-SCI scientists in collaboration with scientists from the
laboratory of Dr. Noel Rose at The Johns Hopkins University Department
of Pathology, showing that pretreatment and early therapy of Experimental
Autoimmune Myocarditis with a compound developed by CEL-SCI resulted in
significant reduction in heart enlargement and disease associated histopathological
changes in mice. The compound used was derived from CEL-SCI's patented
L.E.A.P.S. (Ligand Epitope Antigen Presentation System) platform technology.
These findings could
potentially lead to the development of a treatment for autoimmune myocarditis,
a life threatening heart disease, which is characterized by an enlarged
and weakened heart. Myocarditis is a precursor to dilated cardiomyopathy,
a condition leading to a form of chronic heart failure (CHF) characterized
by an inflamed heart. End stage CHF requires a heart transplant or death
ensues. The incidence in the United States alone of dilated cardiomyopathy
is about 200,000 people.
The protection against
experimentally induced myocarditis was statistically significant for both
pretreatment and early therapy with the L.E.A.P.S compound. The response
was antigen-specific and was associated with an increase in IL-13 in both
the sera and heart tissue and of IL-1 alpha in the sera of the protected
mice. Other studies from Dr. Rose's laboratory with IL-13 knockout-mice
(mice missing the IL-13 gene) demonstrated the importance of IL-13 in this
animal model of Experimental Autoimmune Myocarditis.
Dr. Daniel H. Zimmerman,
Senior Vice President Research, Cellular Immunology, at CEL-SCI said, "These
studies showed that we are able to treat mice with ongoing heart disease.
This may lead to treatment of autoimmune myocarditis in humans where the
disease process is similar to the animal model being studied and reported
here. The issuance of a U.S. patent protecting our novel work is very critical
to our effort."
The most well-known and
common autoimmune diseases are insulin dependent diabetes mellitus, rheumatoid
arthritis, lupus, multiple sclerosis, inflammatory bowel and Graves Disease.
A common thread among these diseases is an immune response that "perceives"
the person's own body, cells and organs as foreign. This, in turn, results
in relentless attacks by the person's own immune system against his/her
own body, eventually leading to debilitating disease, and occasionally
to death. Likewise, the rejection in transplant condition is an immunologically
based reaction. In immune mediated allergic reactions the L.E.A.P.S. vaccine
is intended to redirect the immune response away from the harmful response
in humans to a more subdued response that is not harmful. Current therapies
for these conditions generally treat the symptoms of the disease but not
the underlying cause of the disease as is done with the L.E.A.P.S. vaccine.
L.E.A.P.S. is a novel
T-cell modulation platform technology that enables CEL-SCI to design and
synthesize proprietary immunogens. L.E.A.P.S. compounds ("constructs")
consist of a peptide epitope associated with a disease-causing agent linked
to a T-cell binding peptide ligand (TCBL). Together they induce the immune
system to mount either a cellular (e.g., T-cell), humoral (antibody) or
a mixed immune response as a means to treat, control or prevent disease.
Therefore, L.E.A.P.S. is thought to be a delivery vehicle that directs
or controls the immune response to the desired outcome. This ability to
preferentially direct the immune system is a major breakthrough. Any diseases
for which antigenic epitope sequences have been identified, such as infectious
diseases, cancer, autoimmune diseases, allergic asthma and allergy, are
potential candidates for this technology. More information on L.E.A.P.S.
is available at http://www.cel-sci.com.
The myocarditis work
was supported in part by grants HL071352-01A1, HL67290, HL70729, AI51835
and HL077611 from National Heart, Lung and Blood Institute (NHLBI) and
National Institute of Allergy and Infectious Diseases, Institutes of the
National Institutes of Health (NIH).
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. The Company's lead product Multikine(R) is cleared to enter Phase
III clinical trials with advanced primary head and neck cancer patients.
Other products, in the pre-clinical stage and funded with U.S. government
support, have induced protection against a number of diseases in animal
tests and are being tested against diseases associated with bio- defense
and avian flu.
SOURCE CEL-SCI Corporation
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SmallCap
ETF's.
In
future additions, we will be looking at some of the SmallCap Exchange Traded
Funds (ETF) that have popped up. Most are similar in approach, but we'll
delineate the differences and suggest some of our favorites and why some
would be a good miss. Click
here to view a list of several funds for your initial perusal.
You'll see there are many types vying for your consideration. We'll attempt
to cut the wheat from the chaff for y'all in future articles.
Russell
MicroCap iShares
Would
be interested if anyone has found a chart of the Russell Microcap Index,
which opened last summer. There is an iShare (NYSE:
IWC) based on that index and it has done pretty darn well, up about
20 percent since a low last fall of $48. Volumes aren't that great, averaging
less 50,000-100,000 shares a day, but I suspect it will grow as more folks
get on the SmallCap train. The index is a capitalization-weighted index
and includes companies ranging in total market capitalization from approximately
$50 million to $550 million. Let me know what you think. Or any other
thoughts you may have on the SmallCap market... email
me here...
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