Empresas y finanzas

Callisto Pharmaceuticals Files IND for SP-304 (Guanilib) in Chronic Constipation and Irritable Bowel Syndrome



    Callisto Pharmaceuticals, Inc. (AMEX: KAL; FWB: CA4) announced
    today that through its wholly-owned subsidiary, Synergy
    Pharmaceuticals, Inc. it filed an IND on April 2, 2008 with the FDA
    for SP-304 (also called Guanilib) for the treatment of chronic
    constipation and constipation-predominant irritable bowel syndrome.

    SP-304 is an analog of uroguanylin, a natural hormone produced in
    the gastro-intestinal (GI) tract that is a key regulator of intestinal
    function. SP-304 works by activating a unique receptor, the GC-C
    receptor, on intestinal epithelial cells, promoting fluid and ion
    transport. The drug is administered orally. Nonclinical animal studies
    have shown SP-304 to be well tolerated. Importantly, SP-304 shows
    almost no absorption systemically into the body, exerting its effect
    locally on GC-C receptors within the gut.

    "Callisto is pleased that SP-304 is moving forward on schedule
    into clinical studies. There is strong clinical evidence of efficacy
    and safety for this class of compounds and we are hopeful that this
    product may address the significant unmet medical need of patients
    suffering from chronic constipation and IBS," said Gary S. Jacob,
    Ph.D., CEO of Callisto, and Chairman of Synergy Pharmaceuticals.
    "There are only two compounds presently in this class, our drug, and
    linaclotide, a drug that is currently being developed by Microbia and
    Forest Laboratories to treat GI disorders. We believe that SP-304 has
    the potential to be the best in class."

    In animal models SP-304 has been shown to produce responses
    supporting its potential to reduce symptoms of chronic constipation
    and constipation-predominant irritable bowel syndrome. Pending
    clearance by the FDA, Callisto intends to initiate an SP-304 Phase I
    clinical trial in 2Q2008 to evaluate safety, pharmacokinetic, and
    pharmacodynamic properties.

    About Chronic Constipation

    Chronic constipation is a very common gastrointestinal disorder.
    Up to 26 million Americans suffer from the disorder, and of this
    population about 5 million have a severe condition necessitating
    relief. The prevalence of the disorder is similar in other developed
    countries. Patients with chronic constipation often experience hard
    stools, straining during bowel movements and not enough bowel
    movements during the week. People with chronic constipation can
    experience serious discomfort which adversely affects their ability to
    work and their quality of life.

    Irritable Bowel Syndrome

    Up to one sixth of adults experience inflammatory bowel syndrome
    (IBS), a condition marked by disturbed bowel function and abdominal
    pain. IBS patients can have three different sets of symptoms;
    diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and
    mixed or alternating disorder (IBS-M). The split in prevalence between
    the forms is about 1/3rd each. In addition, most patients suffering
    from the mixed form of IBS (IBS-M) are believed to mainly have
    constipation. An estimated 10 M people in the US and an additional 10
    M people in the EU suffer from IBS-C. IBS (all forms) accounts for 12%
    of adult visits to primary care physicians in the US.

    About Callisto Pharmaceuticals, Inc.

    Callisto is a biopharmaceutical company focused on the development
    of new drugs to treat various forms of gastrointestinal diseases and
    cancer. Callisto´s drug candidates include SP-304, a proprietary drug
    for gastrointestinal disorders that is currently being developed by
    its wholly-owned subsidiary, Synergy Pharmaceuticals, as well as two
    anti-cancer agents. Synergy´s proprietary drug SP-304 (Guanilib) is
    planned to begin clinical development in 2Q2008 for gastro-intestinal
    disorders. SP-304 is a synthetic analog of the human gastrointestinal
    hormone uroguanylin, and acts by activating the guanylate cyclase C
    (GC-C) receptor on epithelial cells of the colon. The Company´s lead
    drug in the clinic, Atiprimod, is presently in a Phase II clinical
    trial in advanced carcinoid cancer, a neuroendocrine tumor, and in a
    Phase II extension trial in advanced carcinoid cancer patients.
    Callisto´s second cancer drug in the clinic, L-Annamycin, is currently
    in a Phase I/II clinical trial in adult relapsed or refractory acute
    lymphocytic leukemia, and in a Phase I clinical trial in children and
    young adults with refractory or relapsed acute lymphocytic leukemia or
    acute myelogenous leukemia. Callisto has exclusive worldwide licenses
    from Genzyme Inc. and M.D. Anderson Cancer Center to develop,
    manufacture, use and sell Atiprimod and L-Annamycin, respectively.
    Callisto is also listed on the Frankfurt Stock Exchange under the
    ticker symbol CA4. More information is available at
    http://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 for the year ended December
    31, 2007, 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.

    Web site: http://www.callistopharma.com