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VOLUME 07: ISSUE 27
Progress,
Promise, & Placebos - Why IMRP May Be Underestimated
When
it rains it pours, but that can be a good thing when it comes to investments
many of you may own. We've got a salvo of great news to get through today,
with the highlight coming from a name we haven't looked at in a while -
Immune Response Corporation (OTCBB:
IMRP).
In
short, they're getting ready to take another major step in the war against
a serious disease...and it may not be the disease you're thinking of.
While we think the R&D effort for all their targeted illnesses makes
the stock a worthy idea, we'll focus in on just one of those opportunities
below.
Before
that though, congratulations are in order for Clearly Canadian (OTCBB:
CCBEF) as well as Siena Technologies (OTCBB:
SIEN).
Siena
announced this morning they were able to undergo a major restructuring
of debt - a move which will save them nearly half of a million dollar
in debt service payments this year. Aside from the timeframes being
extended on a handful of loans, lower interest rates were also negotiated.
The end result? Try about a $40,000 improvement in monthly cash flow.
We
don't think the new financial flexibility could have come at a better time
for shareholders...right as the company seems to be 'turning the corner'.
We suspect having more cash control is going to have a profound effect
in accelerating the company's growth (not that it needed much help in the
growth area to begin with).
As
for Clearly Canadian, all we can say is move over Donald Trump, and look
out Simon Cowell - Clearly Canadian is the newest contender in the 'reality
TV' genre. We first mentioned the possibility of the show in the middle
of last year, but it looks like it's going to become a reality - no
pun intended. As we said then, we feel the kind of publicity this could
generate is almost priceless. And, knowing much of the story firsthand,
we suspect it'll be good TV-watchin' as well.
You
can read more about both announcements in the blog
(yet one more reason why we suggest you bookmark our blog page and check
it often).
In
the meantime, we definitely think you'll want to sink your teeth
into today's news from Immune Response Corporation. See if you're as excited
as we were about the progress of one of their vaccine projects...a project
that could potentially mean millions of dollars.
Immune
Response Drug Takes the Next Step
First
things first - no matter what you may think a couple of seconds from now,
our opinion about Immune Response's press release today is indeed focused
on investors rather than scientists. But, to really appreciate the true
scope of what the company disclosed just a few moments ago, we do think
at least a little background is in order.
You
may best-know Immune Response as the company working on a highly-novel
HIV treatment. The drug is called IR103. It's essentially a vaccine
utilizing the same principles employed by the company's founder Dr. Jonas
Salk when he created the world's first successful polio vaccine. The
'vaccine' approach is a critical difference, as it could potentially avoid
some of the inherent problems with other antiviral therapies presently
being used. But you know what? As impressive as we find IR103 to be so
far, Immune Response reminded us today how investors are likely to be well
served by paying attention to all the details.
Instead
of an update on IR103, Immune Response notified its investors that
the next testing stage of its multiple sclerosis treatment has begun.
The drug's results so far appear to be incredibly promising, so we personally
consider this a huge milestone for the company - and shareholders for
that matter.
In
simplest terms, multiple sclerosis is a condition where a patient's own
immune system has attacked the protective tissue surrounding cells of the
central nervous system. The challenge in treating such a disease is in
not destroying the body's own immune system, but still preventing the
degradation of nerve cells.
Enter
NeuroVax (tm) - Immune Response's answer to the need created by MS.
According to the company's data, over 90% of the MS patients receiving
a NeuroVax treatment in earlier testing showed a "strong disease specific
immune response". Based on the initial results, the company has every
intention of taking the next step in further developing this drug for what
will hopefully be commercial use. In fact, that's today's news - Immune
Response is starting latter phase II trials in its Eastern Europe testing
of NeuroVax....the first patient of a blind-study (a comparison of placebos
against the real thing) has been injected.
Crunching
the Numbers
Now,
this is great news for the company and MS patients. But what about the
opportunity for investors to make some money? We have three quick thoughts
on the matter.
First,
the worldwide MS treatment market is estimated to be worth $4 to $5 billion
each year. This number is expected to grow between 10% and 15% per year.
Do
the math on this one...by 2010, worldwide MS therapy sales could be over
$7 billion. If NeuroVax is approved for commercial use (which is decided
by the regulators within individual countries), Immune Response could start
tapping into a huge well. Even capturing just 5% of the annual market
would mean $350 million in revenue.
Now
think about this - at last count there were only 8.87 million outstanding
shares of IMRP. Their market cap is around $11.9 million.....and
they're looking at a multi-million dollar (perhaps billions?) opportunity....an
enticing disparity. We'd say the MS market's potential alone could
be worth the price of admission.
Second
thing (though in the same vein)....we don't think today's investors
will necessarily have to wait until NeuroVax, or even the company's HIV
treatments, are approved before seeing the share price appreciate. In our
experience, biotech stocks have a way of being 'rewarded' for good R&D
progress. And, we'd say today's news qualifies as progress.
And
lastly, remember in November the discussion we had about some major
players (institutions and/or 'accredited' investors) investing $18 million
in the company? Folks, that's a lot of 'smart money' being put on the table
- we just can't ignore it. They bought their shares at a split-adjusted
$2.00. The only thing that's changed between now and then is the stock's
price - you can own your shares at around $1.18, essentially following
the smart money lead, but beating them at their own game.
No,
NeuroVax isn't on the market yet - and may never be approved anywhere.
However, think about this....the company has enough faith in their MS work
to stay on it. That goes a loooong way with us.
Weighing
the risk against the enormous potential reward, we're far more inclined
take a chance the drug will get at least to some markets, rather than take
a chance it won't. The potential numbers here just look too sweet for us
not to get excited.
Following
in Some Big Footsteps?
Of
course, we'd also be amiss if we didn't remind you of another of our biotech
observations. To really get the maximum benefit of this kind of R&D-related
exposure, we feel you also have to be willing to give it plenty of
time. Case in point - Amgen (NASDAQ:
AMGN). Back in 1988, if you had become an Amgen stockholder - at a
price of 60 cents - you'd be thrilled with your 10,260% gain since then.
If
you're wondering whether or not Amgen was just a stroke of luck, it wasn't.
Teva Pharmaceuticals (NASDAQ:
TEVA) is another one of the many biotech companies with a stock that
went from pennies to big bucks. Trading around 7 cents in late 1984, the
current level of $36.37 is a monstrous 45,362% gain, reaped in a little
more than two decades.
Obviously
we can't guarantee IMRP is going to follow the same path to mind-boggling
returns. We'll say this however - we see a lot of similarities to those
other two companies. None of it will matter if you're on the sidelines
though.
As
cliché as it sounds, investors rarely regret the things they do....they
regret the things they don't do. In our opinion, Immune Response
is the kind of opportunity that makes the cliché true. We think
a few years from now, IMRP could leave a lot of people wondering why they
didn't take action when they had a chance.
THE IMMUNE
RESPONSE CORPORATION INJECTS FIRST PATIENT IN TRIAL OF NEUROVAX(TM) FOR
TREATMENT OF MULTIPLE SCLEROSIS
-- Investigational
Immune Based Therapy Could Provide New Hope to the 2.5 Million Patients
Who Suffer from MS --
CARLSBAD, California,
March 7, 2007 - The Immune Response Corporation (OTCBB:
IMRP) today announced the injection of the first patient in a large
multi-center Phase II study of NeuroVax(tm), an investigational T-Cell
Receptor peptide vaccine for the treatment of relapsing-remitting multiple
sclerosis (MS). NeuroVax(tm) may represent a significant advance in the
treatment of MS, which affects more than 2.5 million people worldwide,
including more than 400,000 in the United States.
"We are pleased
to initiate this important trial," said Dr. Joseph O'Neill, President and
CEO of The Immune Response Corporation. "This study will allow us to examine
the potential of NeuroVax(tm) to help patients with multiple sclerosis,
to better understand our platform technology in autoimmune diseases, and
position our MS program for a strong commercial partnership."
In MS, a specific
subset of a patient's own white blood cells, pathogenic T-cells, attack
myelin, a fatty tissue in the central nervous system, which surrounds and
protects nerve fibers. This pathologic process creates multiple areas of
inflammation that ultimately lead to scarring (sclerosis) and that interfere
with normal transmission of nerve impulses. This nerve damage, in turn,
leads to a variety of chronic and often debilitating neurological symptoms,
ranging from serious movement and balance problems to vision impairment.
NeuroVax(tm),
which is based on the Company's patented T-cell receptor (TCR) peptide
vaccine technology, has shown potential clinical value in the treatment
of relapsing forms of MS. NeuroVax(tm) has been shown to stimulate strong,
disease-specific cell-mediated immunity in nearly all treated patients.
NeuroVax(tm) appears to work by enhancing levels of FOXP3+ regulatory T-cells
(Treg cells) which may help regulate expression of pathogenic T-cells in
MS patients. Previous clinical trials conducted by the Company and other
independent researchers have associated diminished levels of FOXP3+ Treg
cell responses with the pathogenesis and progression of MS and other autoimmune
diseases such as rheumatoid arthritis (RA), psoriasis and Crohn's disease.
In addition to MS, the Company has proprietary technology and prior clinical
experience for evaluation of TCR peptide-based immune-based therapies for
RA and psoriasis.
"By restoring
FOXP3+ Regulatory T-cell functions to levels seen in healthy individuals,
NeuroVax(tm) may offer a new and highly targeted mechanism to control pathogenic
T-cell activity and limit or prevent nerve tissue damage in MS patients,"
said Dr. O'Neill. "Additionally, NeuroVax(tm)'s once-a-month dosing, attractive
side effect profile and ease of manufacture could benefit the millions
of MS patients in need of effective and more tolerable treatment options."
The goal of The
Immune Response Corporation's research program is to develop safe effective
and affordable therapies for patients suffering from devastating diseases.
The Company's investigational vaccines for MS and other autoimmune diseases,
as well as for treatment of HIV, are highly targeted, potentially less
toxic medicines that seek to harness the body's own defenses to control
and possibly prevent disease. This approach may prove valuable in the discovery
of novel immune-based therapies for a host of autoimmune and infectious
diseases.
About the Study
This trial is
a multi-center, randomized, double-blind, placebo-controlled 48-week study
to assess the safety and efficacy of NeuroVax(tm). Two hundred subjects
with relapsing-remitting MS, with an Expanded Disability Status Scale (EDSS)
score of <= 5.5 and meeting all inclusion/exclusion criteria, will be
enrolled in the study in several Central and Eastern European countries.
The first trial patient was injected at a study site in Bulgaria and regulatory
approval to begin enrolling has been obtained in Slovakia. Enrollment will
continue in other countries as pending regulatory approvals to initiate
the trial are approved.
The primary clinical
endpoint of the study is to compare the cumulative number of new gadolinium
enhancing lesions, a key marker of MS disease activity, using MRI scans
at 24, 32, 40, and 48 weeks. Secondary objectives include additional MRI
measurements, analysis of clinical relapses, measures of neurologic disability,
immunologic evaluations, and safety.
Study participants
will be randomized equally to receive NeuroVax (tm) (100 micrograms/mL
of each of three selected TCR Peptides), emulsified in Incomplete Freund's
Adjuvant (IFA) or placebo (IFA) intramuscularly in the deltoid muscle every
four weeks. Evaluation will occur every eight weeks by brain MRI scan and
patients will also undergo evaluation by neurology examinations at 12,
24, 36, and 48 weeks. Safety will be monitored by routine physical exams
that will be performed at 24 and 48 weeks, and lab tests of hematology,
chemistry panel and urinalysis will be performed at weeks 4, 12, 24, 36,
and 48.
About The Immune
Response Corporation
The Immune Response
Corporation (OTCBB: IMRP,
formerly IMNR) is an immuno-pharmaceutical company focused on developing
products to treat autoimmune and infectious diseases. The Company's lead
immune-based therapeutic product candidates are NeuroVax(tm) for the treatment
of MS and REMUNE(r) and IR103 for the treatment of HIV infection. These
therapies are in Phase II clinical development and are designed to stimulate
disease pathogen-specific immune responses aimed at slowing or halting
the rate of disease progression.
NeuroVax(tm),
REMUNE(r) and IR103 are in clinical development by The Immune Response
Corporation and are not approved by any regulatory agencies in any country
at this time. Please visit The Immune Response Corporation at www.imnr.com
for additional information.
This news release
contains forward-looking statements. Forward-looking statements are often
signaled by forms of words such as should, could, will, might, plan, projection,
forecast, expect, guidance, potential and developing. Actual results could
vary materially from those expected due to a variety of risk factors, including
whether the Company will continue as a going concern and successfully raise
proceeds from financing activities sufficient to fund operations and clinical
trials of NeuroVax(tm), REMUNE(r) or IR103, the uncertainty of successful
completion of any such clinical trials, the fact that the Company has not
succeeded in commercializing any drug, the risk that NeuroVax(tm), REMUNE(r)
or IR103 might not prove to be effective as either a therapeutic or preventive
vaccine, whether future trials will be conducted and whether the results
of such trials will coincide with the results of NeuroVax(tm), REMUNE(r)
or IR103 in preclinical trials and/or earlier clinical trials. A more extensive
set of risks is set forth in The Immune Response Corporation's SEC filings
including, but not limited to, its Annual Report on Form 10-K for the year
ended December 31, 2005, and its subsequent Quarterly Reports filed on
Form 10-Q. The Company undertakes no obligation to update the results of
these forward-looking statements to reflect events or circumstances after
today or to reflect the occurrence of unanticipated events.
REMUNE(r) is a
registered trademark of The Immune Response Corporation. NeuroVax(tm) is
a trademark of The Immune Response Corporation.
MEDIA CONTACT:
Rachel Kessler
Chamberlain Communications
Group Inc.
(212) 389-9155
rkessler@chamberlainpr.com
INVESTOR CONTACTS:
Robert Giordano
ROI Associates
(212) 495-0201
rgiordano@roiny.com
Gene Marbach
Makovsky &
Company
(212) 508-9645
gmarbach@makovsky.com
COMPANY CONTACT:
Michael K. Green,
COO
The Immune Response
Corporation
(760) 431-7080
info@imnr.com
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