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VOLUME
04: ISSUE 33
Feature:
BioCurex Update
Never
in over 20 years of market watching have I ever seen anything like the
recent activity in the shares of biotech BioCurex. (BOCX.PK).
SmallCap Digest wants to bring you the latest we have on the company, a
recap and our understanding as to the future timeline of events.
From
relative obscurity last fall when we Alerted
the readership to nifty biotech BioCurex at 20 cents, the shares embarked
on a roller coaster ride in early April, posting massive volumes to eventually
hit a high of $3.90.
The Securities and Exchange Commission
(SEC) subsequently halted BioCurex shares on April 8th for a period of
two weeks for clarification of some of the company's claims. We will deal
with those issues below.
Where can I trade BOCX?
As readers and shareholders have
no doubt noticed, the shares of BioCurex were moved in mid-April, by the
NASD, from the bulletin board market and are now trading in the nether
market known as the Pink Sheets. This development is the result of a standing
NASD rule that relegates any stock from either the NASDAQ or the Bulletin
Board to the pink sheets in the event the stock is halted for trading for
four or more days.
Those shareholders and interested
others who wish to access accurate quotes on the company, BioCurex has
arranged with www.pinksheets.com
to display the company's Level II real-time quotes during this period and
have made them available for free to the general Access them here:
http://www.pinksheets.com/quote/quote.jsp?symbol=BOCX
There is conflicting information
as to whether Pink Sheet stocks can be traded online, depending on which
brokerage firm you use. Investors may have to place their orders with a
human. Best to give your dealer of choice a call and get the proper
format.
Second, BioCurex is working with
all haste to return the company to trading on the OTC Bulletin Board. Commensurate
with that event is the filing of BioCurex's 10k (audited financials), which
the company hopes to accomplish as soon as possible, likely in the next
week or so. The company has already filed an 8k (unaudited financials)
in the interim. That document is available here--under the corporate title
Whispering Oaks International: http://www.sec.gov/Archives/edgar/data/1092562/000100487804000061/0001004878-04-000061.txt
Re-listing on the OTCBB will hopefully
follow quickly once the appropriate forms are filed with the NASD.
FDA 'Approval'
One of the questions the SEC put
to BioCurex was its use of the term ' approved' when linked to its proprietary
cancer detection tissue biopsy test Histo-Recaf?. The company responded
in an April 10th news release:
The Food and Drug Administration
(FDA) has classified BioCurex's Histo-RECAF? as a Class I device under
Regulation Number 864.1850, Code HZJ owned by BioCurex (FDA number 9046509).
Thus, the product is available as a "Staining test for AFP receptors (a.k.a.
RECAF) in tissues" for sale to pathology laboratories across the USA.
The pertinent documents from
the FDA can be found by doing a search for BioCurex at http://google.fda.gov.
I'm happy to argue semantics, but
it seems clear from these statements that the company's diagnostic tissue
biopsy test Histo-Recaf? is' available for sale' according to the
FDA, which, granted, is likely more appropriate than ' approved'. The bottom
line is that BioCurex can sell the Histo-Recaf? test to pathology labs,
nationwide. The company is fully cooperating in any other matters regarding
the SEC's inquiries, including some "spamming' that took place regarding
BioCurex --which the company had absolutely no part in or any knowledge
of-- prior to the SEC halt.
Sensitivity
We see no reason to deviate from
the initial reasons we first brought BioCurex to the SmallCap readership.
The company stands by its stated test results up to and including its April
5th Press release, which announced exciting initial results regarding its
blood test--Serum-Recaf?--for the detection of lung cancer: "BioCurex
Inc. announces results for lung cancer detection using its proprietary
Serum-RECAF(TM) blood test. The results confirm 90% sensitivity with 95%
specificity*.
The findings further substantiate
the use of RECAF(TM) as a universal cancer marker with a potential market
size of $2 billion per year for all cancers."
Sensitivity is the percentage of times
a test detects cancer. Specificity is the percentage of times no false
positives/negatives are recorded.
BioCurex has posted data and an explanation
of its lung cancer detection results (in PDF format) on its website under
'news' for all to read. http://www.biocurex.com/index3.html
Let's talk about sensitivity. To
date, BioCurex's studies--albeit on small numbers of patients-- have determined
that for all the cancers tested with Histo?-and Serum-Recaf?, sensitivity
(detection) is north of 90 percent. In many cases, such as Breast cancer,
the sensitivity is 100 percent.
From our October SmallCap Trading
Alert: In a study that included 147 normal samples and 91 cancer
samples, Histo-RECAF ? delivered a 95 percent detection rate for various
forms of cancer, including cervix, lung, head and neck, among others. BioCurex's
test sensitivity is 100 percent for breast cancer. Current marker tests
detect only 35-50 percent of breast cancer cases.
BioCurex's new diagnostic tests appear
to be vastly superior to older competitive offerings. This seems mainly
due to their extremely high sensitivity and specificity rates as well as
not being single cancer specific as, for example, is the decades-old test
for the PSA marker for prostate cancer and the CEA marker for colon-rectal
cancer. Both tests are much less sensitive (between 15-30 percent) than
BOCX's proprietary tests, which detect the RECAF? cancer marker in many
different types of cancer.
While the tests to date have been
limited to smaller samples, the revenue potential for these diagnostic
tests appear enormous. Remember, diagnostic tests do not require the same
drawn-out regulatory process as is necessary with drug therapies. We have
noted before that should the company license its tests, BioCurex will then
be in a position to move into the next phase of its development--therapeutic
products and pursuits. It may be early days for BioCurex, but indications
are that the company's current products and ongoing R&D could well
revolutionize the way cancer is detected and treated.
We'd like to reiterate the points
we made in our initial piece in October 2003 on BioCurex:
The salient points investors need
to know about BioCurex are:
Focused on the healthcare solutions/diagnostics
space--a $10 billion market expected to grow by double digits annually over
the next half decade;
Cutting edge patented/proprietary technology
for cancer diagnosis, tumor imaging and treatment;
Identifies the presence of cancer through
detection of a biomarker known as RECAF?. Research indicates BioCurex's
products may detect cancer much earlier than existing technologies;
A sensitivity (detection) rate of 90-100
percent of cancers through either blood, tissue biopsies or other specimens
tested;
High sensitivity for breast and lung
cancer--the most common cancer varieties;
No competitor approaches the detection
rate of BioCurex's diagnostic products;
BioCurex holds the patent for the RECAF?
biomarker*;
Early cancer diagnosis cuts healthcare
costs significantly--an extremely important benefit as those costs continue
to rise.
*RECAF? is a cancer marker found
on malignant cells from a variety of cancer types but is absent in most
normal or benign cells.
We have no evidence that any of these
claims by the company have changed. As well, even through this challenging
period for the company, discussions with potential licensees continue.
As BioCurex stated on April 2nd, it intends to finalize at least one major
licensing deal and several smaller ones during calendar 2004. The company
will continue to test its products and technologies to enhance their initial
validation. Results from Japan and France are expected soon.
Let me put it into simple terms:
what if you could have a blood test annually at the doctor to prove or
disprove the presence of cancer? Think of the lives that would be saved.
What would that be worth to you? Everything.
For investors, what would it be worth
to the marketplace? I would submit that should these proprietary tests
from BioCurex become commonplace --regardless of even any future corporate
developments--the potential could well be staggering.
Hopefully, in the not too distant
future, the regulatory challenges will be behind the company and it can
again focus completely on its important work.
And shareholders can get back to
the business of following, unfettered, this exciting, early-stage biotech.
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