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Newsletter
November 28, 2005
Volume VI, Issue 101
Home Page : www.otcjournal.com
Email Questions or Comments To: editor@otcjournal.com

To OTC Journal Members:
 

Comments in the BLOG

If you review the last BLOG entry on UpSnap (OTC BB: UPSN) you will note I called for $2.40 as the perfect entry level, with a stop loss at $2.30. The stock is trading there now, and therefore at the perfect entry level technically. I would only give this one a $.10 cushion- if it trades at $2.30 or much lower just take your loss and move on no matter what level you own it at. There is also a new BLOG entry on Global ePoint (NASDAQ: GEPT) which had a huge day last week. It was long overdue. 

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. The most current journal entries appear in the middle of your screen. 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 question.
 

Callisto Pharmceuticals (AMEX: KAL) Takes On Colon Cancer

KAL has added colon and rectal cancer to its portfolio of potential cancer therapies. Today, just after the market closed, KAL announced it received notification from the US Patent office granting notice of allowance (edited: formal approval to follow) for a patent of a novel drug compound created by Callisto scientists to treat and prevent a variety of inflammatory diseases of the bowel, including colon cancer.  The drug is first-in-class of a new category of compounds with the potential to revolutionize therapy for gastro-intestinal disease, while presenting virtually no known side effects or toxicity.

Frost & Sullivan estimates the size of the market in the US for colon and rectal cancer to be in the neighborhood of $2.58 billion in 2006. It is the third leading cause of cancer mortality in the US.

The press release describes a revolutionary new approach to treating this particular hard to treat version of cancer. SP304 (the compound's lab name) is delivered orally, and mimics a naturally-occurring hormone called uroguanylin, which is normally produced in the body’s intestinal tract. 

Replacing this hormone with a very close cousin is expected to reduce inflammation in damaged cells. The compound is so close to its naturally occurring cousin that KAL scientists anticipate little or no toxicity associated with this orally administered drug.

With a little luck, this news could put a major charge into this stock. Colon and Rectal cancer are both highly visible and problematic forms of cancer. Both are difficult to treat. Both have the highest incidence in people over 50, which is the current bulge of population known as the "Baby Boomers".

I would expect this news to be picked up by major national media outlets. With any luck at all, this news should get KAL moving back up the charts. Since first publishing on the company on October 1 at $1.30, we have seen the stock trade as high as $1.62 and as low as $1. The $1.30 introduction level was in the middle of the range.

While the stock succumbed in the October correction, it has yet to participate in the November rally. As of today's close, KAL was trading at about the $1.10 level, nearer the low end of its range.

Historically, the next two weeks of the year tend to be a little on the quiet side, with the market picking up towards in the second half of December. In light of this news, KAL promises to have a strong finish going into the year end.

With the addition of a potential therapy for colon and rectal cancer, KAL adds a powerful new component to its already rich portfolio of treatments for Leukemia, Multiple Myeloma, and bioterrorism threats

Stanford Research has a $5 price target on KAL, which it derives from the current valuations of comparable companies VION, BIVN, and CTIC.

Combining additional blockbuster drugs to its already strong pipeline is going to bring this stock into investors cross hairs sooner or later. I'm hoping for a huge day tomorrow. We are certainly due to have one.

Here is the complete text of today's news for your review:
 

Press Release Source: Callisto Pharmaceuticals, Inc.

Callisto Announces Newly Allowed Patent on First-in-Class Drug for Colon Cancer and Other Diseases

Monday November 28, 4:01 pm ET

Research Data Supports Drug's Potential as Revolutionary, Safe, Non-Toxic Preventative for Cancer and Treatment for Gastro-Intestinal Diseases

NEW YORK--(BUSINESS WIRE)--Nov. 28, 2005---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 that the U.S. Patent and Trademark Office has given a Notice of Allowance on a patent for a novel drug compound created by Callisto scientists to treat and prevent a variety of inflammatory diseases of the bowel, including colon cancer. The drug is first-in-class of a new category of compounds with the potential to revolutionize therapy for gastro-intestinal disease, while presenting virtually no known side effects or toxicity.

The Callisto drug candidate, currently 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. People with colon cancer lack sufficient quantities of uroguanylin, and this deficiency is linked with colon carcinogenesis. SP304 is designed to replace the naturally occurring compound, but with the added advantage of providing greater anti-inflammatory potency and therapeutic effect. Also significantly, because Callisto's SP304 is a close molecular relative of the naturally occurring hormone, it is anticipated to be virtually non-toxic.

"Research in animal models has indicated that this new class of compounds and therapeutic approach, represented by Callisto's drug SP304, has the potential to genuinely revolutionize the treatment of certain very serious inflammatory bowel diseases, as well as colon cancer," said Dr. Gary S. Jacob, CEO and CSO of Callisto. "The science behind SP304 is an exciting new avenue in cancer and anti-inflammatory treatment research, and Callisto is proud to be the first to patent a drug in this groundbreaking, next-generation category of potential therapies."

Callisto's SP304 drug candidate is designed to help replenish damaged cells in the lining of the colon -- cells that may become cancerous -- to function as therapies for people who have gastro-intestinal diseases such as ulcerative colitis or colon cancer. It also is being evaluated as a preventative measure to stop cancer and other diseases from developing.

One of the major physiological functions of uroguanylin is the regulation of cell health in the colon lining, including the elimination of mutated cells and the replenishment of healthy cells. "This delicate balance of elimination and renewal of the cells of the colon lining is crucial to the prevention of cancer. We believe SP304 can be an effective oral therapy to prevent benign colorectal polyps from becoming cancerous," said Dr. Kunwar Shailubhai, Senior Vice President, Discovery Research for Callisto, who is one of the drug's inventors. "Research data has also shown the drug to have very impressive anti-inflammatory properties, suggesting it is an excellent candidate as a treatment for inflammatory bowel diseases such as ulcerative colitis."

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.

The Notice of Allowance for Callisto's SP304 was given for the patent titled, "Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis." The USPTO has allowed key claims covering the composition of matter of the SP304 compound; additional claims are pending in divisional applications.

"This patent allowance is a scientific and strategic milestone for Callisto that further strengthens our pipeline of significant drug technologies and our mission to develop needed new medical treatments," added Dr. Jacob.

About Callisto Pharmaceuticals, Inc.

Callisto is a biopharmaceutical company committed to developing innovative new drugs to treat cancer and other major diseases and health threats. Currently, the Company's drug development pipeline includes anti-cancer drugs to treat blood, or hematological, cancers, and related diseases, as well as new drugs with Homeland Security applications designed to protect against potential bio-warfare agents, including staphylococcus and streptococcus. Currently, Callisto is developing two anti-cancer drug candidates to treat multiple myeloma and leukemia, both serious blood cancers. The Company's L-Annamycin drug candidate is presently planned to enter a clinical trial to treat adult relapsed or refractory acute lymphocytic leukemia (ALL) in Q4 2005. L-Annamycin has a novel therapeutic profile that includes the potential to treat patients whose cancers have shown resistance to other cancer drugs; it also has shown potential for significantly reduced cardiotoxicity, or danger to the heart, compared with existing anthracycline cancer drugs. Callisto's anti-cancer drug Atiprimod is being explored as a treatment for relapsed or refractory multiple myeloma. Atiprimod is currently in a Phase I/IIa clinical trial in relapsed or refractory multiple myeloma patients at four clinical sites in the United States. In addition to cancer treatments, Callisto is developing a drug pre-clinically for treatment of ulcerative colitis. Callisto also has received a major biodefense partnership grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a monoclonal antibody and vaccine against bacterial superantigen toxins. Bacterial superantigens are among the most lethal of toxins that can potentially be used as bioweapons. 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, please 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 x227
dagostino@callistopharma.com
or
Trilogy Capital Partners, Inc.
Paul Karon, 800-592-6067 (Financial Communications)
paul@trilogy-capital.com

Source: Callisto Pharmaceuticals, Inc.


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