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March
7, 2006 |
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Volume
VII, Issue 21 |
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Home Page : www.otcjournal.com
Email Questions or Comments To:
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Callisto Pharmacueticals (AMEX: KAL); Sets
Sites on Potential Colon Cancer Therapy
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Callisto in on the verge of
developing a myriad of cancer therapies, any or all of whom could put this
stock at considerably higher levels. Consider there are only about 40 million
shares issued and outstanding. At the $1.60 level, where
the stock has been grinding, the entire value of the company is only $64
million.
You would be hard pressed to find
a publicly traded company, with a promising cancer therapy in Stage III
clincal trials, trading below a $200 million market capitalization. KAL
has
the financial resources in the bank right now to get both Atiprimod
and Annamycin to the Stage III levels.
A couple of comparisons include VION
($141 million) and BIVN ($314 million). Both companies are working
on cancer therapies and in or nearing Stage III clinical trials.
They don't need to successfully introduce
their products into the market for shareholders to enjoy substantial returns.
The market knows their therapies will become very valuable to big pharma
as they come with a year to 18 months of an FDA Approval. The big pharmacueticals
companies need to keep their pipelines stuffed with the next generation
of revenue producing therapies to replace the ones that go generic. They
shop for smaller companies as they close in on potential revenue generating
therapies.
As we get further down the road,
KAL
becomes either a very attractive acquisition candidate or a good candidate
for a marketing partnership. Either one would place the stock at considerably
higher levels.
I thought last week's announcement
concerning Atiprimod as a potential therapy for metastatic tumors
would send the stock to a new high. The stock made a valiant effort, but
simply traded back down to the current $1.60 range. A symptom of
the current anemic market conditions.
Perhaps today's news will do the
trick. Today, post close, KAL announced some new information about
Guanilib- it's potential treatment for uorguangtin deficiency in the colon.
Uroguanylin is a naturally occuring
hormone found in the colon. A lack of uroguanylin is associated with polyps,
tumors, and GI intestinal disorders. KAL is developing Guanilib,
a compound that mimics uroguanylin and can be taken orally.
Dr. Scott Plevy, Associate
Professor of Medicine and Immunology and the Co-Director of the Inflammatory
Bowel Disease Center at the University of Pittsburg Medical Center, Pittsburg,
PA is a principle collaborator on Callisto’s Guanilib research program.
Dr. Plevy's abstract on Guanilib (SP304) was accepted for poster presentation
at the Digestive Disease Week Conference in May, 2006.
Dr. Plevy has done extensive
animal testing on the compound. This abstract, a fancy science word which
translated means research paper, is the first step towards the commercializtion
of the product. This therapy can now be added to the growing list of potential
home runs in KAL's treatment portfolio. The May conference will be the
compound's "coming out" party.
As you can see from the chart, KAL
is really trying hard to find its way to a new high. The stock did not
have the energy to make it last week, but perhaps today's news will rally
the troops.
Ultimately, with all the irons this
company has in the fire, one is bound to get hot. I don't know if tomorrow
is the day, or its sometime down the road. I would continue accumulating
at about $1.60 with a stop loss in the $1.40 range. When
the next streaky move comes, you can offload some or all. For now, the
company is moving forward rapidly on many fronts. It should pay off for
investors somewhere down the road.
Here is the complete text of today's
news for your review:
| Press Release Source:
Callisto Pharmaceuticals, Inc.
Animal Data on Callisto's
Drug Candidate Guanilib to be Presented at Key Scientific Conference on
Digestive Diseases
Tuesday March 7, 4:01
pm ET
Guanilib Found to Reduce Key Causative
inflammatory Mediators in an Animal Model of Ulcerative Colitis
NEW YORK--(BUSINESS WIRE)--March
7, 2006--Callisto Pharmaceuticals, Inc. (AMEX:KAL - News; FWB:CA4), a developer
of new drug treatments in the fight against cancer and other major health
threats, announced today that an abstract on Guanilib (SP304), Callisto's
drug candidate for gastrointestinal inflammation, was accepted for poster
presentation at the Digestive Disease Week Conference in May 2006.
The abstract on Guanilib,
which involves a collaboration with a team of scientists at the University
of Pittsburgh School of Medicine, headed by Dr. Scott Plevy, a well-known
research and clinical gastroenterologist, and scientists at Callisto, will
be presented at the annual meeting of the Digestive Disease Week (DDW),
a leading scientific conference covering diseases of the digestive tract.
The meeting will be held at the Los Angeles Convention Center in Los Angeles,
California, May 20-25, 2006.
The Callisto drug candidate
Guanilib, also known by its laboratory name SP304, is an orally deliverable
compound designed to mimic a naturally-occurring hormone called uroguanylin,
which is normally produced in the body's intestinal tract. Deficiency of
this hormone is predicted to be one of the primary reasons for the formation
of polyps that can lead to colon cancer, as well as debilitating and difficult-to-treat
GI inflammatory disorders such as ulcerative colitis.
The abstract presentation
at the DDW meeting, entitled: "SP304, An Analog of Uroguanylin, Ameliorates
Inflammation in a Model of Experimental Colitis" authored by Refaat Hegazi,
Fengling Li, Gabriel Calilao, Antonia Sepuveda, Kunwar Shailubhai and Scott
E. Plevy, will describe results suggesting that oral administration of
Guanilib ameliorates inflammation in a mouse model of experimental colitis,
presumably via downregulation of the key cytokines, such as tumor necrosis
factor, that are known to be involved in the causes of IBD. For more information
on the conference, visit http://www.ddw.org.
Dr. Scott Plevy, Associate
Professor of Medicine and Immunology and the Co-Director of the Inflammatory
Bowel Disease Center at the University of Pittsburg Medical Center, Pittsburg,
PA, is a principle collaborator on Callisto's Guanilib research program.
"We are very encouraged
by the Guanilib data from Dr. Plevy's laboratory, and pleased to have this
new research presented to leading research professionals in the field,"
said Callisto CEO Dr. Gary S. Jacob. "Dr. Plevy and his group were the
first to demonstrate that Guanilib inhibits gastrointestinal inflammation
in an animal model of colitis, and now are providing insight into just
how Guanilib exerts its antiinflammatory activity. Their research supports
our commitment to pursue development of Guanilib as a completely new approach
to the treatment of gastrointestinal disease."
One of the major physiological
functions of uroguanylin is in the regulation of the continual renewal
process, which is to eliminate mutated or damaged cells and replenish them
with healthy new cells. "This delicate balance of elimination and renewal
of the cells of the colon lining is crucial to the prevention of cancer
and other GI inflammatory disorders. Guanilib is first-in-class of a new
category of compounds called guanylate cyclase receptor agonists (GCRA)
with the potential to provide a new way to treat gastrointestinal diseases,
while exhibiting minimal side effects or toxicity," said Dr. Kunwar Shailubhai,
Senior Vice President, Discovery Research for Callisto, who is one of the
co-authors of the abstract and also one of the inventors of the GCRA technology.
A patent allowance covering
therapeutic applications of this compound in GI inflammatory diseases has
recently been granted by the U.S. Patent and Trademark Office. "This patent
allowance is a scientific and strategic milestone for Callisto," added
Dr. Jacob.
More than 500,000 Americans
are afflicted with ulcerative colitis, a type of inflammatory bowel disease
(IBD) that causes chronic inflammation of the digestive tract. Along with
Crohn's disease, the other major form of IBD, ulcerative colitis can be
painful and debilitating, and can lead to other serious and life-threatening
complications. There is currently no medical cure for ulcerative colitis.
Colon cancer, also called
colorectal cancer, is the second leading cause of cancer death among men
and women in the United States and Canada, and is the third most diagnosed
cancer, excluding skin cancer. The American Cancer Society estimates that
there will be 146,940 new cases of colorectal cancer diagnosed in the U.S.
in 2004 -- roughly one new case every 4 minutes. Although colon cancer
can be treated through surgery, chemotherapy and radiation, currently there
are no drugs specifically designed for its prevention and treatment.
About Callisto Pharmaceuticals,
Inc.
Callisto is a biopharmaceutical
company focused on the development of new drugs to treat various forms
of cancer and other serious afflictions. Callisto's drug candidates in
development currently include anti-cancer agents in clinical development,
in addition to drugs for a range of other significant health care market
segments, including biodefense. One of the Company's lead drug candidates,
L-Annamycin, is being developed as a treatment for forms of relapsed leukemia,
a currently incurable blood cancer. Callisto initiated a clinical trial
of L-Annamycin in adult relapsed acute lymphocytic leukemia patients in
4Q 2005. L-Annamycin, a new compound from the anthracycline family of proven
anti-cancer drugs, has a novel therapeutic profile, including activity
against resistant diseases and significantly reduced cardiotoxicity, or
damage to the heart, compared to currently available drug alternatives.
Another anti-cancer drug, Atiprimod, is in development to treat relapsed
multiple myeloma, a blood cancer. Atiprimod has entered Phase I/IIa human
clinical trials in relapsed multiple myeloma patients. Callisto also has
drugs in preclinical development for gastro-intestinal inflammation, and
a program focused on the development of a drug to protect against Staphylococcus
and Streptococcus biowarfare agents. Callisto has exclusive worldwide licenses
from AnorMED Inc. and M.D. Anderson Cancer Center to develop, manufacture,
use and sell Atiprimod and L-Annamycin, respectively. For investor-specific
information about Callisto, including recent news and stock price data,
please visit http://www.trilogy-capital.com/tcp/callisto/. For an Investor
Fact Sheet about Callisto, please visit http://www.trilogy-capital.com/tcp/callisto/factsheet.html.
To view an informational presentation of the Company's development pipeline
of drug candidates, visit http://www.trilogy-capital.com/tcp/callisto/powerpoint.html.
Callisto is also listed on the Frankfurt Stock Exchange under the ticker
symbol CA4. For additional information, visit www.callistopharma.com.
Forward-Looking Statements
Certain statements made
in this press release are forward-looking. Such statements are indicated
by words such as "expect," "should," "anticipate" and similar words indicating
uncertainty in facts and figures. Although Callisto believes that the expectations
reflected in such forward-looking statements are reasonable, it can give
no assurance that such expectations reflected in such forward-looking statements
will prove to be correct. As discussed in the Callisto Pharmaceuticals
Annual Report on Form 10-K/A for the year ended December 31, 2004, and
other periodic reports, as filed with the Securities and Exchange Commission,
actual results could differ materially from those projected in the forward-looking
statements as a result of the following factors, among others: uncertainties
associated with product development, the risk that products that appeared
promising in early clinical trials do not demonstrate efficacy in larger-scale
clinical trials, the risk that Callisto will not obtain approval to market
its products, the risks associated with dependence upon key personnel and
the need for additional financing.
Contact:
Callisto Pharmaceuticals,
Inc.
Dan D'Agostino, 212-297-0010
ext. 227
dagostino@callistopharma.com
or
Trilogy Capital Partners,
Inc.
(Financial Communications)
Paul Karon, 800-592-6067
paul@trilogy-capital.com
Source: Callisto Pharmaceuticals,
Inc. |
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Comments in the BLOG
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So far this week there are no new
BLOG
entries. Comments for long suffering shareholders of Family Room
below. The stock has been revived. The BLOG is primarily used as
a mechanism to comment on trading activity in stocks we follow. We are
currently in a nearly comatose market environment, so volatility is absent,
and therefore BLOG posting are scarce.
To use the BLOG, simply go
to the home page at www.otcjournal.com
- the BLOG will scroll down automatically on the right side of your
screen. You can look there by company. The most current journal entries
appear in the middle of your screen in chronological order. Check back
frequently for updates particularly when stocks are moving to overbought
or oversold levels or in volatile markets. Your questions and postings
do not automatically appear, so don't bother posting the same question
multiple times. I personally go through to moderate and respond to every
reasonable question. |
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16 Blocks Puts Charge Into
Family Room (OTC BB: FMLY)
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FMLY has surfaced in the past
few trading days and is coming off the carpet with a vengence. This is
the kind of volume we needed when the stock was $.10 to keep it healthy.
Apparently, the market is very excited about the positive early reviews
on 16 Blocks with Bruce Willis, to be released into theaters this month.
Last summer FMLY registered
47 million shares to cover convertible debt. The shares I&O went up
by about 19 million into February, suggesting there were 28 million left
to be sold.
Since last week, the stock has traded
130 million shares. It is probably safe to assume that the financiers have
sold all the stock they could sell, and probably paid off about $1/2 million
of the remaining $1.234 million in convertible debt, leaving about $700k.
If FMLY makes producer profits
and uses the money to pay off the remaining debt, the dilution could be
over. If they are going to continue to pay in stock, they will probably
have to file another registration statement, and they may be running out
of authorized stock.
Either way, the supply could be completely
dried up at this point, and the stock might actually do well from here.
I currently own no shares, but might punt and pick up a million or so at
about the $.02 level- if it ever gets back there.
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