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VOLUME
06: ISSUE 40
CEL-SCI
Delivers Positive Data
We've
been covering CEL-SCI (AMEX:
CVM) off and on now for almost four years. Both times we initiated
coverage, first back in November
of '02 and again in February
of this year, the stock went on to reward our readers substantially
for the year. Therefore, we like to think we have come to know this story
as good as anyone, and let me tell you, this story is really starting to
get good.
If
you don't own any CVM now, you best consider adding some to your portfolio
on any pullbacks in the stock near-term, as the Company appears to be getting
closer to its planned Phase III clinical trials. With recent data released
and the changing tide in the Biotech arena, small companies such as CVM
hold tremendous upside potential in our opinion, as the pipeline for new
cancer drug studies is comparatively scarce.
At
1:15 PM ET Tuesday, CEL-SCI announced the highly anticipated release of
long-term survival data from its Phase II clinical trials in patients with
head & neck cancer. The addition of Multikine as the first-line treatment
prior to the standard of care treatment resulted in a 33-40% improvement
in the median survival at 3 1/2 years post-surgery (release below).
Multikine first-line treatment also resulted in a 2-year local regional
control (LRC) rate of 79%, as compared to the median 2-year LRC of 73%
reported in 39 scientific publications previously published. Local regional
control (LRC) is the increased ability to delay the recurrence of the tumor.
Bottom
line is these results revealed substantial improvement in both the survival
rate and the local regional control of tumors for cancer patients who received
Multikine over 3 years ago. This is significant, as the data are thought
to be directly applicable to CEL-SCI's planned global Phase III study.
This clearly bodes well for the Company, which has already received the
Phase III go-ahead from Canadian regulators.
Killing
Cancer Worth Billions...and lives.
Drug
sales for cancer treatments are expected to more than double over the next
five years, with cancer drugs replacing cholesterol-reducers as the number
one pharmaceutical sector, according to a report from IMS Health. Right
now, it's probably the fastest growing drug sector, with oncology drug
sales projected to reach $55 billion in 2009.
With
its recent release of data and CEL-SCI's push toward a Phase III clinical
trial, the future revenue prospects for the Company becomes mind boggling
with potential. Cancer is America's second-biggest killer behind heart
disease. Genentech (NYSE:
DNA), one of the most prolific names in cancer treatment, is reaping
the benefits of growing sales with its colorectal cancer drug, Avastin,
posting record revenue in excess of $1 Billion in 2005 and is projected
to achieve 6.9 billion a year in sales by 2009.
To
put it into perspective, Avastin is a treatment provided in conjunction
with chemo, which received FDA approval based on data demonstrating a five-month
improvement in the median survival of patients treated with Avastin plus
the chemotherapy regimen compared to other patients. Sound familiar? Maybe
Avastin and Multikine should be used together. We'll leave that up to the
scientists and the FDA.
Genentech's
market cap currently fluctuates around $82 Billion. CEL-SCI's sits around
$65 Million. Which appears to have more room for growth? It will likely
take a 100-pound gorilla, a crane and a few missiles to launch shares of
Genentech to new highs in the coming months ahead. If CEL-SCI can get an
FDA go-ahead for its Phase III clinical trials, we believe the stock is
at least an overnight double.
Although
we feel exposure to biotech is well warranted right now, regardless whom
you choose to invest in, we can all find comfort in the fact that these
companies are helping to save lives. Likely at one point or another
throughout our lives, we've all had someone close to us diagnosed with
cancer. When someone we know ends up having to battle this unbelievably
ruthless disease, I think it becomes quite apparent why we tend to gravitate
toward companies that develop cures or life extending drug treatments for
those in need.
Hence,
just another reason why I'm always willing to bet a few bucks on the companies
I believe are at the forefront of biotech research and development.
And,
the Technical Picture
Investing
and Trading are two completely different animals. Within trading, we have
various species. What are you? Predefine that and you are so far ahead
of the game, it's not even funny. I'll do an edition on that soon.
For
now, shares of CVM are as good as it gets for traders, when you're on the
right side of the trade. The stock has had huge run-ups on at least five
separate occasions in the last five years. However, its most recent rocket
move during the week of April 7th was on record volume. Blow away record
volume to be more precise. Like I've said before, volume is your friend.
It is one of the few leading indicators that one can use to identify buy
or sell signals in stocks that simply aren't behaving with any sort of
normalcy. The amount of volume displayed in CVM's latest move suggests
much higher levels of interest in the stock than ever before. This
is often the case prior to major moves in small stocks.
This
weekly chart shows shares of CVM violated the 5/8-retracement level from
the run up that started back in February of this year, although the retracement
was on fairly light volume, we would have preferred it hold the $.90 cent
level. However, it's more interesting to note that prior to the big run-up
in CVM recently, the move came off a higher trading base than its previous
level. After the news hit the market yesterday, shares of CVM traded as
high as $1.15 before backing up a bit at the close. We like the momentum
in the stock right now.
We
believe yesterday's announcement will provide a new catalyst, we like the
prospects of CVM shares making a move to the $1.30 - $1.40 level. From
there, we'll reassess the chart. Use any short-term weakness in the stock
as a potential entry point. A trading stop of $.85 cents is suggested.
If
you're an investor, I'd tuck some away for a rainy day. The market loves
to reward investors when they least expect it.
Press Release
CEL-SCI Presents Long-Term Survival
Data With Its Anti-Cancer Drug Multikine(R)
Tuesday May 23, 1:15
pm ET
VIENNA, Va., May 23 /PRNewswire-FirstCall/
-- CEL-SCI CORPORATION (Amex: CVM - News) announces the presentation of
long-term survival data from its Phase II clinical trial in patients with
head & neck cancer (oral squamous cell carcinoma -- OSCC) treated with
its anti-cancer drug Multikine®. The addition of Multikine as first-line
treatment prior to the standard of care treatment resulted in a 33-40%
improvement in the median survival at 3 1/2 years post-surgery, when compared
to the results of 39 OSCC clinical trials published in the scientific literature
between 1987 and 2004. The data were presented at the "Vaccine Discovery
and Commercialization" conference in Philadelphia, PA.
The long-term survival
data were collected by the treating physicians in a follow-up study of
22 patients with advanced untreated primary tumors, who were enrolled in
the Multikine Phase II clinical trial. The Multikine treatment regimen
was administered to these patients prior to the standard of care treatment
(i.e., surgery + radiation or surgery + chemo-radiation). Informed consent
was obtained from all patients in the clinical trial and from 19 patients
for the long-term follow-up study. Investigational Review Board / Ethics
Committee approval was provided before the initiation of the clinical trial
and again for the data collection in the follow-up study. The follow-up
study questionnaire assessed the overall survival and the local regional
control of the Multikine treated patients in this Phase II trial.
Documented data were
available for 19 of the 22 patients in the follow-up portion of this clinical
trial. Of the three patients who could not be evaluated in the follow-up
study, one patient was known to be alive, but failed to give informed consent,
and the other two were lost to follow-up. One patient died the day after
definitive surgery, unrelated to Multikine therapy.
The median overall survival
(calculated by including death from any cause of patients in the trial,
even deaths not related to the disease) of the 19 evaluable patients in
the follow-up portion of this clinical trial was 63% at a median follow-up
of 40 months post-surgery. The results of the published scientific literature
(39 OSCC clinical trials published between 1987 and 2004) document that
survival at 3 1/2 years is approximately 47% following standard of care
treatment. The addition of Multikine to the standard of care treatment
resulted in a 33% increase in overall survival over the results published
in the literature.
The median survival of
patients in this clinical trial was 67% at a median follow-up of 42 months
post-surgery, excluding the one patient with immediate post-operative death.
The same 39 scientific publications indicate that survival at 3 1/2 years
is approximately 47% following standard of care treatment. The addition
of Multikine to the standard of care treatment resulted in an increase
in survival of 40% over the results published in the literature.
Multikine first-line
treatment also resulted in a 2-year local regional control (LRC) rate of
79%, as compared to the median 2-year LRC of 73% reported in the same 39
scientific publications. Multikine treatment resulted in an improvement
over the published local regional control rate. It is clinically recognized
that recurrence of disease in head & neck cancer is associated with
a very poor prognosis.
Multikine treatment did
not result in any severe adverse events (SAE) in this Phase II clinical
trial. No SAEs related to Multikine have been reported in other trials
conducted with Multikine either.
The data from CEL-SCI's
Multikine Phase II clinical trial are thought to be directly applicable
to CEL-SCI's planned global Phase III clinical trial, as the Multikine
treatment regimen planned in the Phase III trial is identical to that of
the Multikine treatment in the trial reported here. Furthermore, the planned
endpoints of the Phase III trial are local regional control, disease-free
survival and overall survival, all of which have shown improvement compared
to historical controls, following Multikine first-line treatment over the
current available treatments for these patients.
Head & neck cancer
is an aggressive cancer that affects 500,000 people per annum worldwide,
and approximately 2/3 of patients present with advanced disease.
Multikine is a patented
immunotherapeutic agent consisting of a mixture of naturally-occurring
human cytokines, including interleukins, interferons, chemokines and colony-stimulating
factors, currently being developed for the treatment of cancer.
CEL-SCI Corporation,
with operations in Vienna, VA and Baltimore, MD is developing new immune
system based treatments for cancer and infectious diseases. CEL-SCI's other
products are currently in the pre-clinical stage of development. Pre-clinical
animal studies have received U.S. government support. The results of these
studies indicate these products may offer protection against a number of
diseases. The agents are being tested, among others, against diseases associated
with bio-defense and avian (bird) 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 for the year ended
September 30, 2005. 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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Biotech
in Focus
For
those religious biotech followers who missed our SC
Blog yesterday morning, one of the industry's biggest weeks of the
year is just around the corner. And, if you don't think there's going to
be a few biotech stocks that are going to make huge moves in the coming
weeks after, think again. Look what happened to Amgen's stock, (NASDAQ:
AMGN), last year in the few months following the big pow-wow. ASCO
takes center stage in Atlanta this year June 2nd -- June 6th.
Consider
it the modern day Woodstock for cancer drugs, except everyone has grown
up, dresses nicer and speaks much more eloquently. Maybe that's a bit of
a stretch, but nevertheless, it's the most important event of the year
for companies looking to gain recognition and tout their most recent advancements
in the forever-coveted arena of cancer research and development.
ASCO
is a non-profit organization, founded in 1964, with overarching goals of
improving cancer care and prevention and ensuring that all patients with
cancer receive care of the highest quality. More than 23,000 oncology health
care practitioners belong to ASCO, representing all oncology disciplines
(medical, radiologic, and surgical oncology) and subspecialties.
The
ASCO Annual Meeting is considered the premier educational and scientific
event in the oncology community. The Meeting attracts more than 29,000
attendees from all over the world, from street analysts to the most renowned
cancer research and development scientists on the planet; ASCO is a who's
who gathering of biotech big wigs.
If
you're interested in learning more about the industry, the ASCO
web site is loaded with valuable and insightful information.
What
is this going to do for certain biotech stocks in the few months following
ASCO? I think we're in for a short-term biotech rally. I say short, because
we're talking about a trade here, not an investment. Whatever comes of
ASCO, you'll likely have time to invest in the weeks after, if that's what
you choose to do.
For
now, let's have a quick look at the BTK,
which is the Amex Biotech Index, and the IBB,
which is the NASDAQ ETF for Biotech stocks. In
this weekly chart of the BTK, you can see the index has sold off of
late in sympathy with the broader markets, we've circled its 3/8-retracement,
where it currently is hovering, but point to the 5/8, which would be an
even more ideal entry point, obviously. All of our favorite technical indicators
are pointing to an oversold market for biotech right now, so I suspect
we'll see a tradable rally leading into ASCO, and good follow through in
the right stocks following the meeting.
Inevitably,
it would be no surprise to see the BTK clean up the 5/8 retracement level
sometime this summer. If you agree with our thinking, some exposure to
sector wide puts may be in order at the top of the short-term rally anticipate.
Of
the two, the IBB appears riper for a rally (you can't directly trade the
BTK anyway). Keep in mind, the BTK and the IBB are made up of different
stocks, so different price action makes clear sense. The IBB, as shown
in this weekly
chart, currently sits on a nice 5/8-retracement level (circled). We
point out the volume of late in the chart, which has been fairly substantial,
so we like that. A clean up of the $70 level would be no surprise at all,
and would represent an excellent entry for a trade to the long side.
Whatever
you decide, pay attention to ASCO. It will tell many of us where the industry
is going over the next couple of years, and likely who will be leading
it there.
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