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Callisto Pharmaceuticals to Open Atiprimod Phase II Extension Trial in Neuroendocrine Cancer



    Callisto Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer
    of new drug treatments in the fight against cancer and
    gastrointestinal disorders and diseases, announced today the plan to
    open a multi-center, open-label, Phase II extension trial of Atiprimod
    in patients with low to intermediate grade neuroendocrine carcinoma
    (advanced carcinoid cancer).

    This trial will allow patients who successfully completed 12
    treatment cycles of Atiprimod in the Phase II, open label,
    proof-of-concept study that is currently underway to continue to
    receive Atiprimod treatment. Patients must continue to show stable
    disease or better or continue to show at least a 20% decrease in
    symptoms to be eligible to receive Atiprimod treatment in the
    extension clinical trial. The primary objectives of this Phase II
    extension clinical trial are to evaluate the safety and efficacy of
    long-term Atiprimod treatment in patients. Further details of this
    trial can be found at http://www.clinicaltrials.gov.

    "We have patients who have now been on our drug for as long as 12
    months in the Phase II, open-label trial in neuroendocrine cancer and
    want to continue to receive treatment with Atiprimod," said Dr. Gary
    S. Jacob, Chief Executive Officer of Callisto. "By February of 2008 we
    expect the bulk of patients to have been treated for 6 months or more
    with our drug in the ongoing Phase II trial. At that time, we
    anticipate releasing interim data from the trial as well as planning
    for a meeting with FDA on the design of a registration trial."

    About Atiprimod

    Atiprimod is an orally bio-available small molecule drug that
    displays multiple mechanisms of action. The drug has been shown to be
    antiangiogenic, inhibit secretion of VEGF and IL-6, elicit an
    apoptotic response (programmed cellular death), and inhibit
    phosphorylation of key kinases involved in tumor progression and
    survival including Akt and STAT3. The drug is presently in two
    clinical trials: a Phase II trial in advanced carcinoid cancer
    patients, and a Phase I/IIa human clinical trial in relapsed or
    refractory multiple myeloma patients. Callisto earlier announced in
    June, 2006 interim data from a Phase I trial of Atiprimod in advanced
    cancer patients. The patients who were entered into this trial had
    growing tumors and symptoms that were no longer controlled by the
    standard therapies utilized. During treatment, three of the five
    advanced carcinoid patients had measurable tumor regressions and loss
    of many of the debilitating symptoms of this disease.

    About Carcinoid Cancer

    Carcinoid tumors, or carcinoids, originate in hormone-producing
    cells of the gastrointestinal (GI) tract, the respiratory tract, the
    hepatobiliary (liver) system and the reproductive glands. The most
    common site of origin is the GI tract, with tumors often developing in
    the rectum, and other sections of the small intestine. Approximately
    7,000 cases of carcinoid cancer are diagnosed in the U.S. annually,
    with the number increasing over the past 20-30 years. Carcinoid tumors
    that metastasize to the liver have a poor prognosis. Traditionally,
    chemotherapy relieves symptoms in less than 30% of cases of metastatic
    carcinoid tumors, usually for less than 1 year. Carcinoid tumors
    typically produce a condition called "carcinoid syndrome" which is
    caused by the release of hormones by the tumors into the blood stream.
    The symptoms vary depending on which hormones are released by the
    tumors, but typically include diarrhea, facial flushing, wheezing,
    abdominal pain and valvular heart disease.

    About Callisto Pharmaceuticals, Inc.

    Callisto is a biopharmaceutical company focused on the development
    of new drugs to treat various forms of cancer and gastrointestinal
    diseases. Callisto's drug candidates in development currently include
    anti-cancer agents in clinical development, in addition to drugs in
    pre-clinical development for other significant health care markets,
    including gastrointestinal disorders. One of the Company's lead drug
    candidates, Atiprimod is presently in a Phase II clinical trial in
    advanced carcinoid cancer patients, a neuroendocrine tumor, and in a
    Phase I/IIa human clinical trial in relapsed or refractory multiple
    myeloma patients. Another anti-cancer drug, L-Annamycin, is being
    developed as a treatment for forms of relapsed or refractory acute
    leukemia, a currently incurable blood cancer. L-Annamycin is currently
    in a Phase I 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. L-Annamycin, a member of the anthracycline
    family of proven anti-cancer drugs, has a novel therapeutic profile,
    including potential activity against multi-drug resistant tumors and
    significantly reduced cardiotoxicity, or damage to the heart, compared
    to currently available drug alternatives. Callisto also has a
    proprietary drug Guanilib in preclinical development for
    gastro-intestinal disorders. 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, 2006, 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.

    Callisto Pharmaceuticals, Inc.

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