Callisto Pharmaceuticals Opens Additional Site for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients

    NEW YORK, March 12 /PRNewswire-FirstCall/ -- Callisto Pharmaceuticals,
 Inc. ( KAL; FWB: CA4), a developer of new drug treatments in the fight
 against cancer and other major health threats, announced today the addition
 of the Physician Offices at Mount Sinai Medical Center in New York, NY to
 its Phase II clinical trial of Atiprimod to treat low to intermediate grade
 neuroendocrine carcinoma (advanced carcinoid cancer). The Principal
 Investigator at this clinical site is Max Sung, M.D. Richard Warner, M.D.
 and Elizabeta Popa, M.D. will be sub-investigators for this study. Other
 major cancer centers are currently reviewing the trial protocol, and the
 Company anticipates additional sites will be added to the trial.
     "The addition of the Physician Offices at Mount Sinai Medical Center to
 the Phase II trial of Atiprimod in advanced carcinoid patients signifies
 our continuing commitment to facilitate rapid enrollment of this trial,"
 said Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "The Physician
 Offices at Mount Sinai specializes in the treatment of neuroendocrine
 cancers, and has built a significant reputation within the carcinoid
 community, which should substantially enhance the pace of enrollment and
 increased accessibility to prospective patients interested in participating
 in this trial."
     The primary objective of the Phase II clinical trial is to evaluate
 efficacy of Atiprimod in patients with low to intermediate grade
 neuroendocrine carcinoma who have metastatic or unresectable cancer and who
 have progression of their disease despite standard therapy (octreotide).
 Patients, after signing an informed consent, are required to complete two
 weeks of a symptoms diary to establish their symptoms baseline before
 commencing Atiprimod dosing. A maximum of 40 evaluable patients will be
 enrolled in this trial. Efficacy evaluations will include the measure of
 target lesions (per RECIST), and the quantization of symptom relief.
 Further details of this trial can be found at http://www.clinicaltrials.gov
 .
     The other two sites currently participating in this Phase II trial are:
 1) the Hematology Oncology Services of Arkansas in Little Rock, Arkansas,
 and 2) the Dana-Farber Cancer Institute in Boston, MA.
     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 other serious afflictions.
 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 ulcerative
 colitis. One of the Company's lead drug candidates, Atiprimod, is in
 development to treat advanced carcinoid cancer, a neuroendocrine tumor, and
 relapsed multiple myeloma, a blood cancer. Atiprimod is presently in a
 Phase II clinical trial in advanced carcinoid cancer patients, and in Phase
 I/IIa human clinical trials in relapsed or refractory multiple myeloma
 patients, and advanced cancer patients, respectively. 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. Callisto
 initiated a clinical trial of L-Annamycin in adult relapsed or refractory
 acute lymphoblastic 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. Callisto also has drugs in
 preclinical development for gastro-intestinal inflammation, and cancer.
 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. 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/A for
 the year ended December 31, 2005, 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.
 
 

SOURCE Callisto Pharmaceuticals, Inc.