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VOLUME 06: ISSUE 85
Another
Cancer Test Evolution
You
know how athletes sometimes talk about taking their game to the 'next level'?
It's just a succinct way of describing the change from average performance
to superior performance (or even from superior to improbable performance).
Although you don't hear sports analogies too often in the investing world,
we think the phrase 'next level' is an appropriate description for one
of the projects of a company we've been following for a while. BioCurex
(OTCBB: BOCX), by
way of an announcement a few moments ago, looks like it may have taken
a cancer detection test to a 'next level' of its own. Investors, potential
or otherwise, should obviously take note, as the most recent evolution
of the company's RECAF test is still in its infancy.
And
just so you know where all this is going, we'll begin with the two-point
grand finale. One, the RECAF test results so far make it appear
to be a far better (i.e. more accurate) option than other (i.e. current)
cancer detection tests. Two, the potential dollars up for grabs
in the market is just enormous. Take a look, and see what you think.
Proof
of the Pudding
If
you're not familiar with BioCurex's RECAF cancer detection test, it may
be worth reviewing two key points. In simplest terms, it seems to work
better than current alternatives, and has repeatedly found cancer in its
early
stages...when
cancer is much easier to beat. Not only are current cancer tests less accurate,
they also tend to only spot later stages of cancer, when treatment is much
less effective. Just look at the test results we've covered in just the
last few months.
April
11th: RECAF
detects early stages of breast cancer with high specificity. Patients
afflicted with either early Stage 1 or Stage 2 breast cancer were 'marked'
by the RECAF test with a sensitivity exceeding 90 percent, and 100 percent
specificity (or no false positives). Mammography has a sensitivity of 65-75
percent, and has a specificity of 90 percent, which translates into 10
percent false positives.
July
19th: RECAF
twice as effective as current prostate cancer test (or PSA). The standard
PSA test showed a sensitivity of 48% with 60% specificity. The specificity
could be increased to 70%, but at the expense of doubling the cost. By
comparison, using the company's RECAF test on the same cancer and benign
samples, the sensitivity was 90% with a specificity of 84%.
October
17th: RECAF
tests accurately in detection of gastric cancer; no other biomarker
specifically detects gastric cancer. Third party (non-BioCurex) research
reported a 73% sensitivity with 97% specificity using Histo-RECAF for tissue
examination in gastric (stomach) cancer detection tests.
Get
the first point now? The RECAF test is superior at detecting at least three
kinds of cancer, and the company expects to see similar detection results
as more and more types of cancer are tested. Why wouldn't the medical community
embrace a better tool?
The
'News'
As
fully described in the press release below, BioCurex announced today they
have successfully performed RECAF tests using a light-based detection format
rather than a radiation-based format.
The
radioactive version of the test uses a radio-immunoassay to find radioisotopes
serving as a specific biomarker, highlighting the presence of any cancer.
Since tiny amounts of radioactivity can be measured with the appropriate
equipment, the result is an assay that can detect trace amounts of an individual
substance like RECAF in a blood sample. The test results cited in the previous
section were achieved using radio-immunoassays.
The
light-based test can yield similar results, but through a technology called
chemoluminescence. That's just the fancy word for a biological 'tag' emitting
light when it reacts with certain chemicals. The presence of cancer would
create a certain light signature that wouldn't be seen otherwise.
How
well does it work? It works as consistently as the traditional version
of the test. On 68 prostate cancers (Stages I and II) the new format detected
71% of cancers with 87% specificity. Only 27% of these samples exhibited
a PSA higher than 4 ng/ml (the value above which there is the suspicion
of cancer). While the common the PSA test would not have spotted the cancer,
the RECAF test was able to detect these early cancers. On 28 miscellaneous
cancers, which included more advanced stages, the sensitivity was 86% with
95% specificity.
So
what? Keep reading.
Similar
Technology in Use by Other Companies
If
the old detection test format worked well enough, then what does it matter?
We'd
be the first to admit not being sure whether or not this was even 'news'.
If the results were the same, what would it matter? However, a re-read
of the press release, and some research above and beyond that, uncovered
that using light-based instruments to find particular 'signatures' is a
direction that a big chunk of the industry seemed to be moving in.
Take
Applera Corp-Celera Genomics Group (NYSE:CRA)
for instance. The company is utilizing the idea of spectrometry, or light-based
instruments, to identify unusual levels of proteins, relative to normal
levels, in human cells. The company believes spotting the difference in
protein levels (peptides, actually) will be an affective means of distinguishing
between normal and potentially-diseased cells...effectively serving as
a detection test. The high throughput equipment used by Applera is the
same type of tool that BioCurex's new RECAF test will be utilizing. This
'proteomics' effort at Celera is currently focused on pancreatic cancer,
lung cancer, colon cancer, and breast cancer. Notice that the only target
disease in common with BioCurex's research (so far) is breast cancer.
Digene
Corp. (NASDAQ:DIGE) is
another biotech company using light-based, high throughput equipment like
BioCurex will now be abe to use. But, Digene is waging their war on diseases
such as human papillomavirus (HPV) - the primary cause of cervical cancer
- with a slightly different approach. Their detection process comes in
two stages. The first stage is the introduction of so-called 'probes' into
the potentially infected patient. These probes are designed to only attach
to the DNA of a specific virus or bacteria. When test results are analyzed,
the presence or absence of the target DNA is determined by a particular
chemiluminescent reaction. Digene's methodology looks promising, but cancer
is not their primary target.
And
how does the use of light-based immunoassays affect BioCurex? Let's just
say it's huge. One of the company's key partners, Abbott Laboratories (NYSE:ABT),
won't
use radio-immunoassays. It's not like they absolutely have to in order
to fulfill their role to BioCurex; Abbott has semi-exclusive rights
to market RECAF technology, which doesn't necessarily require them to provide
the equipment that can actually analyze said tests. BUT, even a casual
observer would have to wonder about the conflicting message there.
Abbott
is no slouch - they control about 1/3 of the diagnostic equipment market.
If they wouldn't use equipment despite that fact that one of
their licensors required its use, then there was clearly a limitation
in place. Odds were/are that other major diagnostic equipments outfits
were also avoiding the use of radio-immunoassays for the same reasons.
The result is a very limited - and perhaps even shrinking - functionality
for the RECAF test.
Well,
there is indeed more to the story. As it turns out, radioactive isotopes
are a logistical pain....no surprises there. As you may suspect, radioactive
materials, even as minimally radioactive as these tests require, are heavily
regulated by the government - transporting them includes a lot of (too
much) regulatory red tape. Plus, they have a limited life span. If the
materials sit on a shelf too long, they become useless, and therefore,
a waste of money.
Colorimetric
(light-based) materials, on the other hand, offer advantages such as a
longer shelf life, greater convenience and easier shipment.
It's
no wonder radio-immunoassays are considerably less desirable than the chemoluminescent
alternatives.
The
upside should be clear, but if it's not, we'll spell it out.....the more
labs that are able to use the colorimetric RECAF test, the bigger the potential
market for BioCurex is. The new test format is directly compatible
with a larger number of instruments used in most clinical laboratories.
Many research laboratories also have chemoluminescence readers, so BioCurex
can ship demonstration kits for further validation of their previous work
- an
important concept we discussed just a few days ago.
The
bottom line is, the announcement brings BioCurex one step closer to the
commercialization of RECAF cancer test.
The
Opportunity
Rather
than dazzle you with some accounting forecasts that, to be honest, don't
quite do the opportunity justice, we'd rather just hit some key points
- to provide some real perspective.
The PSA
test market alone each year is worth half of a billion dollars (yes,
with a 'b'), but prostate cancer only accounts for about 1/3 of all
cancer among men. BioCurex is obviously effective at spotting those
cases early, however...
As the
result of ongoing research, it's becoming clear RECAF may be useful
in detecting many types of cancer other than just prostate cancer,
thus widening the playing field. More than that...
There
are now more than 11 million new cases of cancer diagnosed globally
each year. By 2020, it's expected there will be 15 million new cases
per year, with the number to keep growing after that. Plus...
While
not all cancer cases are actually diagnosed with a test, many cancer tests
are taken with a negative (non-cancerous) diagnosis. Point being, the
number of potential cancer test kits needed each year could also number
in the millions. Figure that...
BioCurex's
test kits will be priced - conservatively - anywhere between $10 and $30
(at least for the radio-immunoassay version). Factor in...
Abbott
reports about $20 billion in sales each year, which is 1/3 of the diagnostic
market. Obviously the RECAF test isn't the only item they sell, but with
the market share (and marketing leverage) controlled by Abbott, even
BioCurex's thin sliver of Abbott's pie is still a big piece of pie.
And don't forget, Abbott's deal is only semi-exclusive; other doors may
be opened later.
It's difficult
to really gauge just what kind of potential dollars this could mean for
BioCurex...but it's big. We know it's on the order of millions if the RECAF
test validity continues to grow as it currently is, which for BioCurex
- and by extension, its investors - would be a gigantic windfall.
For
aggressive investors who can see the 'bigger picture', tolerate the risk,
and are willing to be patient during the early R&D stages of RECAF,
BioCurex is well worth monitoring. The question is simple - if you liked
what you know about RECAF so far, do you think the medical community and
other investors will too?
Press Release
Source: BioCurex, Inc.
BioCurex presents
new format for blood test detection of cancer with results superior to
PSA
RICHMOND, Canada,
October 25, 2006. -- BioCurex Inc. (OTCBB:BOCX)
announced today that it has presented its first set of results using a
colorimetric version of its RECAFTM blood test for cancer detection at
the annual meeting of the International Society for Oncofetal Biology and
Medicine in Pasadena, CA. The results exhibited that this colorimetric
version of BioCurex's RECAF test detected more than twice the amount of
cancers than the most widely used cancer detection test utilized today
- the PSA test.
BioCurex previously
obtained excellent results with a radio-immunoassay format. An immunoassay
takes advantage of the exquisite specificity of an antibody to detect one
and only one substance - in our case RECAF - among the hundreds of different
molecules in serum. A radio-immunoassay uses a radioisotope as a tag and
since minute amounts of radioactivity can be measured with the appropriate
equipment, the result is an assay that can detect trace amounts of an individual
substance (RECAF) in the serum. Radio-immunoassays have now been successfully
used for almost 50 years but the use of radioactivity and their short life-span
due to radioactive decay has prompted the search for alternative way to
detect the reaction (it should be noted that the amount of radioactivity
used is minute, but its use as well as shipment is heavily regulated by
government agencies).
Most high throughput
automated systems - such as the Abbott ArchitectTM - use chemoluminescence
which is based on a tag that emits light when it reacts with certain chemicals.
By convention, tests that rely on light to measure the reaction are called
"colorimetric assays". They offer advantages such as a longer shelf life,
greater convenience and easier shipment.
The results referred
herein were obtained with chemoluminescence and they represent a significant
step forwards to implementing the RECAF test in the automated instruments
supported by clinical laboratories.
On 68 prostate
cancers (Stages I and II) the new format detected 71% of cancers with 87%
specificity. Only 27% of these samples exhibited a PSA higher than 4 ng/ml
(the value above which there is the suspicion of cancer). Therefore the
PSA test would not have raised suspicion whereas the RECAF test was able
to detect these early cancers.
On 28 miscellaneous
cancers, which included more advanced stages, the sensitivity was 86% with
95% specificity.
Dr. Moro stated:
"We are very happy with these results since this new format is directly
compatible with many high throughput automated instruments used in large
clinical laboratories. Many research laboratories also have chemoluminescence
readers and therefore BioCurex can now ship demonstration kits to other
scientists for further validation of our previous work, something not easy
to do with a radioactivity based kit (due to shipping restrictions).
Dr. Moro added:
"This breakthrough brings us one step closer to the commercialization of
our unique cancer test. We have more work to be done to optimize the assay
for improved detection comparable to our radioimmunoassay results. We will
need to test more samples before we are finished, and there are also other
colorimetric formats that we want to implement as well. However, our active
participation and collaboration with others to develop this new testing
method is rewarding. We are particularly pleased with the development of
this format since the know-how gained can be transmitted to all of our
future licensees, and it worked well with early stages of prostate cancer.
As a matter of fact, it detected more than twice the cancers that PSA would
have detected".
About BioCurex:
BioCurex, Inc.
is a biotechnology company that is developing products based on patented/proprietary
technology in the areas of cancer diagnosis, imaging and therapy. The technology
identifies a cancer marker known as RECAFtm, which is found on malignant
cells from a variety of cancer types but is absent in most normal or benign
cells.
BioCurex has signed
a licensing agreement with Abbott Laboratories for BioCurex's RECAFTM Cancer
technology as outlined in a joint press release dated March 29, 2005. The
release noted that the cancer marker RECAFTM has emerged as a potential
biomarker that may be useful in the development of new cancer diagnostics
tests. Preliminary studies from the investigators at BioCurex have reported
a high level of clinical sensitivity and specificity for RECAF in many
of the most common cancers, including prostate, breast, colorectal, lung
and others.
To read more about
the Company, please visit the News section in our web site (www.BioCurex.com).
Note:
The Company has
not authorized the release of this information in any form that contravenes
the Communication Act and will not be responsible for unsolicited massive
distribution of this material by e-mail or facsimile by unauthorized parties.
Statements in this press release, which are not historical facts, are "forward-looking
statements'' within the meaning given to that term in the Private Securities
Litigation Reform Act of 1995. The Company intends that such forward-looking
statements be subject to the safe harbors created thereby. Since these
statements involve risks and uncertainties and are subject to change at
any time, the Company's actual results could differ materially from expected
results.
Contact:
Ricardo Moro
BioCurex, Inc.
Tel: (604) 207
9150
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Multicell
Assembles A Biotech Dream Team
You've
got to respect a company that tells you what they're going to do, then
goes out and does it. So, kudos to Multicell Technologies (OTCBB:
MCET), as they just confirmed progress in the development of an MS-related
fatigue treatment. The drug is now entering latter phases of testing in
the United States on the heels of promising Phase IIb testing in the United
Kingdom. Where is it all going? If the drug treatment progresses satisfactorily
through phase II and then phase III clinical trials, Multicell will be
the only treatment provider for the MS-related fatigue market...estimated
to be worth a total of $3 billion during the period that Multicell would
be protected by its patent.
Read
the rest by clicking
here.
Earnings?
Who Needs Earnings When You're In The Car Business?
OK,
despite the fact that we were bullish on the auto industry (per the July
19th blog entry), even we have to admit a little shock about the Dow
Jones Automobile Index (DJUSAU) being up more than a full percentage point
on Monday. Why? Ford (NYSE: F)
reported a mere $5.8 billion loss in their third fiscal quarter...the worst
loss in over 14 years. As if it weren't bad enough, they're looking for
things to be even worse next quarter! So how badly were Ford shares hit?
Shares closed 1.3% lower. Frankly, I'm surprised it wasn't worse, especially
in light of all the profits that could be taken, with the stock 30% above
its June low of $6.06.
Even
more impressive is the strength the rest of the auto sector is showed despite
the problems that the nation's second biggest auto-maker confirmed. Normally
this group's icon, at least the domestic one, would serve as a proxy for
the rest of these stocks. Not this time though. The market is shrugging
it off, assuming not all of these symptoms have infected the rest of the
players in the auto industry. And with Ford gaining 4.5% on Tuesday, the
market doesn't seem to even think Ford's symptoms are even infecting Ford.
What's
our take? Hey, we're not going to fight the crowd here. The fact that the
group is higher despite plenty of reasons not to be tells us the buying
interest goes deep. Maybe Toyota Motor (NYSE:
TM), General Motors (NYSE:
GM) and other auto manufacturers are still worth a look, as mentioned
in the blog a handful of times a few weeks ago. The charts sure look pretty
solid to us.
Two
Encouraging Charts: EAG, and CVM
You
ever heard the phrase 'The bigger they are, the harder they fall'? It can
be true of stocks as well. Most investors get a little nervous (and rightfully
so) when an issue puts up giant gains in just one day - it almost always
seems to invite a reversal.
However,
it isn't necessarily a bad thing. You just have to exercise a little patience
when - or even if - responding to the surge. Not one, but two of our focus
company stocks may be a prime illustration of this point.
On
the 16th, CEL-SCI (AMEX: CVM)
rocketed from 67 cents to 76 cents, resulting in a one-day gain of 13%.
The gain was impressive, but wound up being too much, too quickly. The
stock eased back to a low of 70 cents four days later, after trading as
high as 81 cents the day after the big gain. It pays to keep watching when
you get such a move. CEL-SCI shares were up to as high as 79 cents on Tuesday,
quickly recovering from the pullback seen just a few days earlier.
Eagle's
(AMEX: EAG) chart went through
the same process, getting launched from 76 cents to $1.03 on the 16th (and
had been as high as $1.12). The stock fell back, all the way to 70 cents
by Monday. But, the 20 day moving average line acted as support, and pushed
shares back up to a high of 90 cents on Tuesday. That's a 25% gain from
Monday's close...and probably one that not many people figured was going
to materialize.
To
see charts of both stocks, click
here.
The
implications? There are two. First, there's always more to the story than
one or two days. In this case, the surge may have been a brief flash of
what the market really thinks about CEL-SCI's or Eagle's stock. The dip
was just a second chance at a low entry point. Pay attention to high volume
rallies, even if the immediate result is a dip. Second, buying on a dip
is like catching a falling knife, but simultaneously, buying after a big
move isn't really any smarter. The best course of action is probably somewhere
in between. To make the most of these opportunities though, you have to
keep these names on your radar for a while - to see how they play out.
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cumulatively referred to as "SCD") , is an independent electronic publication
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TGR Group LLC has been paid a fee
of $15,000 by MultiCell Technologies for coverage of the company. In addition,
TGR Group LLC has been pledged 100,000 warrants with an exercise price
of $.60, convertible into restricted shares of Multicell, and 100,000 warrants
with an exercise price of $.40, convertible into free trading shares of
Mutlicell by Trilogy Capital Partners for coverage of the company.
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of $25,000 cash and 115,000 shares of newly issued restricted stock by
Eagle Broadband for coverage of the Company.
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of $25,000 and 150,000 shares of newly issued restricted stock by Cel-Sci
for coverage of the Company. Additionally, back in November of 2002, TGR
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restricted stock of Cel-Sci for coverage of the company until November
of 2003. The aforementioned 250,000 restricted shares became free trading
under SEC rule 144 and were sold in the open market prior to the company
entering into a new contract agreement with TGR Group in February of 2006.
TGR Group LLC has been paid a fee
of $25,000 and one million newly issued restricted shares by Biocurex for
coverage of the company. Under SEC Rule 144, all one million issued restricted
shares are now eligible for sale into the public market. TGR Group has
submitted the appropriate filings to sell the shares. In addition, on March
22, 2005, TGR entered into an extended agreement with Biocurex for a fee
of 25,000 newly issued restricted shares and on July 1, 2006 TGR entered
into another extended agreement with Biocurex for an additional 100,000
shares of newly issued, restricted stock.
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