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VOLUME
06: ISSUE 15
Feature:
The Key to Defeating Cancer; Increasing Survival Rates.
The
bottom line to successful cancer treatment is relatively straightforward:
the longer this deadly scourge can be held at bay or put into remission,
the better a patient's chance of survival. That's a concept Big Pharma,
which tends to focus on toxic end-of-life or chronic treatment drugs--has
yet to grasp.
That's not the case with a lot of
smallcap biotechs including unique cancer drug/therapeutics company CEL-SCI
(AMEX: CVM).
As we stated in our recent Trading
Alert shares of CEL-SCI should be accumulated at these levels and on
any dips by risk-oriented investors for what will be, in our opinion, superior
gains over the next 6-12 months.
As we saw in our previous coverage
of CEL-SCI in 2002-2004, the shares can move quickly (21 cents to almost
$2 in a few months) and decisively as investors wake up to the potential.
Using recent volumes as our guide, we believe that we are on the threshold
of a similar type of trading activity.
At
current levels, CVM appears to want to retrace a 5/8 move of the January
2005 high to the October 2005 low. The shares could well see 83 cents as
a result before running into some resistance. Should they hit that level,
we'll reassess. Shares of CVM have increased nicely --up 35 percent to 70-plus
cents, Monday, from our recent Alert price of 52-cents.
Volumes have been robust and a sustained
break above 60-65 cents would do well to move the shares up into a new
and higher trading range. Investors will note that the shares have been
consolidating between 50-60 cents for a while now.
Improving Cancer Survival Rates
Currently, the median survival rates
for advanced primary head and neck cancer patients following traditional
treatments are about 50 percent after 3 years.
Apparently that patient survival
number could well be about to rise significantly. In today's release (below),
biotech CEL-SCI states that results from a 3-year follow-up to its previous
Phase 2 Multikine study indicated that:
"Multikine-treated patients
had substantially increased survival rates and achieved a higher rate of
2-year local regional control as compared to the survival and the 2-year
local regional control rates published in the scientific literature."
The "failure of local regional control"
in Head and Neck Cancer is when the tumor recurs above the clavicle following
surgery/therapy. If it recurs, patients will die. If it does
not, they have a longer time to live or may be cured, unless it recurs
in the lung.
As stated in the release, the endpoint
of CEL-SCI's planned Phase 3 Multikine trial is to show significantly improved
survival rates as well as enhanced regional control of tumors.
Precise results from CEL-SCI's long-term
Phase 2 follow-up cannot be released just yet due to the data being prepared
for publication. In our opinion, it is reasonable to assume that they will
likely prove to be very good.
Think of the Head and Neck Cancer
results as a potential 'proof of concept' for Multikine. Efficacy with
this aggressive form of the cancer, which has had little treatment improvement
over the last two decades, will likely translate into treatments for other
forms of cancer--which we have noted in the past-- as well. Canada has already
approved a Phase 3 trial and hopefully the FDA will follow suit soon. We
think both are extremely exciting developments for both CEL-SCI and its
shareholders.
When compared to other Phase2/3
companies, CVM's market cap of around $45 million is a mere shadow
of its peers. The majority of these companies, like CVM, make no revenue
to speak of yet, but have been bid up significantly by investors who see
the potential. Investors have apparently ignored the potential of CVM,
which we feel is both a mistake and, more importantly, an opportunity for
those risk-oriented shareholders who decide to participate now.
PRESS RELEASE
Multikine Treatment Increases Survival
in Cancer Patients
Feb 21, 2006 10:07:00
AM
VIENNA, Va., Feb. 21
/PRNewswire-FirstCall/ -- CEL-SCI Corporation (Amex:
CVM) announces positive results from a long-term follow-up study of
head & neck cancer patients treated with its drug Multikine(R) in a
Phase II clinical trial. The follow-up study indicated that Multikine treatment
resulted in a substantial increase in the survival of patients. In addition,
Multikine treatment also improved local regional control of the patients'
tumors. Improved local regional control of the tumor is considered by many
surgeons and oncologists to be an important measurement of the success
of a head & neck cancer drug. Both survival and local regional control
of the tumor are stated endpoints in CEL-SCI's planned Phase III clinical
trial.
The Phase II study, which
used the same Multikine treatment protocol as proposed for the Phase III
trial, included advanced primary head & neck cancer patients who were
scheduled for their first cancer treatment. The Multikine treatment was
administered for 3 weeks prior to the standard treatment for head &
neck cancer, surgery or surgery plus radiation/chemotherapy. Results from
this study were published in a leading cancer publication, the Journal
of Clinical Oncology (Timar et al, JCO, 23(15): May 2005).
The median follow-up
period for the patients was 3.2 years. The results of the Phase II trial
follow-up study showed that the Multikine-treated patients had substantially
increased survival rates and achieved a higher rate of 2-year local regional
control as compared to the survival and the 2-year local regional control
rates published in the scientific literature (39 clinical trials between
1987 and 2004 in a similar population of head & neck cancer patients).
At this time, CEL-SCI cannot provide the detailed results of this long-term
follow-up study of Multikine treatment as the data are currently being
prepared for publication.
Maximilian de Clara,
President of CEL-SCI, states, "These results suggest that Multikine has
the potential to bring much needed benefit to patients with head &
neck cancer, a disease that has significant morbidity and mortality and
for which there has been little improvement in therapy over the last 20
years. We are very excited by these results and hope to repeat these very
promising results in our Phase III clinical trial."
CEL-SCI received the
go-ahead for its proposed Phase III trial from the Canadian drug regulatory
authority in August 2005. The same proposed Phase III trial was submitted
to and discussed with the United States Food and Drug Administration (FDA)
in two separate End of Phase II meetings held during 2005. Following each
of these meetings the FDA requested that additional information be provided.
CEL-SCI has recently completed the submission of all of the additional
information the FDA requested and awaits the FDA's response.
Head and neck cancer
is an aggressive cancer that affects about 500,000 people per annum worldwide.
About 92% of those cases are outside of the U.S., and about two thirds
of all cases present with advanced disease.
Multikine is a patented
immunotherapeutic agent consisting of a mixture of naturally occurring
cytokines, including interleukins, interferons, chemokines and colony-stimulating
factors, currently being developed for treatment of cancer.
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 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 shown protection against a number of diseases in animal tests
and are being tested against diseases associated with bio-defense and avian
flu.
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/A for the year ended
September 30, 2004. 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.
SOURCE CEL-SCI Corporation
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TGR Group, LLC
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Oil,
Canada.
Lots
of chatter about Canadian stocks as traded on the Toronto Stock Exchange.
Primarily a resource market, oil, gold and natural gas shares have propelled
the TSX index from 9000 in January 2005 to almost 12,000 today. Stocks
like oil and gas behemoth Encana (NYSE:
ECA) and Barrick Gold (NYSE:
ABX) have risen and fallen with the volatile commodity prices and
are likely worth a look should one feel that the downtrend is reversing.
Canada is the largest single supplier of oil and gas to the US. Lots of
focus on the Athabasca Tar sands--which is black, oily gloop that if tapped,
could help the US meet its national oil dependence goals without mid-east
oil. Some estimates have Alberta sitting on nearly a trillion barrels of
oil with varying difficulty of recovery. The Mideast has 685 billion barrels
recoverable. The higher oil goes, the more attractive that gloop becomes,
as it is extremely expensive to extract. Apparently Calgary and Edmonton
have recently been inundated with US Congressional types looking over the
goods. Good stuff, eh? Better learn the metric system...
Mac
and Geez...
McDonalds
(NYSE: MCD) is being
sued for having not disclosed that it uses wheat and milk in their French
fries. Crap, it's likely the only goodness in these heart cloggers. Yes,
they should have disclosed these ingredients earlier, but doesn't this
just seem like clown-chasing lawyers looking for a cause? The stock's up
20 percent since September and I suspect will continue to appreciate as
we get larger and hungrier and this ridiculous case goes away.
Against
next year's projected earnings of $2.40 a share, the slimmest thing for
MCD is the compelling15 times p/e. What ever happened to boycotts? Guess
they weren't profitable enough.
And
what's up with that Burger King guy in the mask in their commercials? He
creeps me out.
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