Atiprimod Clinical Trial in Advanced Cancer Patients Uncovers Clear Response against Carcinoid Tumors; Company Plans New Clinical Trial, New Results May Accelerate Atiprimod's Path to Approval.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Callisto Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :KAL)(FWB (Fixed Wireless Broadband) See fixed wireless. :CA4), a developer of new drug treatments in the fight against cancer and other major health threats, today announced plans to launch an additional indication for clinical development of its drug candidate Atiprimod based on encouraging clinical results that showed a clear response in a patient with advanced carcinoid carcinoid /car·ci·noid/ (kahr´si-noid) a yellow circumscribed tumor arising from enterochromaffin cells, usually in the gastrointestinal tract; the term is sometimes used to refer specifically to the gastrointestinal tumor cancer plus additional encouraging clinical data on other carcinoid patients. The encouraging data provides an additional development path for Atiprimod that has the potential to give Callisto its first approved drug considerably earlier than the Company previously expected. Based on these new clinical data, the Company announced its commitment to initiate a new Phase I/II clinical trial of Atiprimod in carcinoid cancer patients with advanced tumors that it plans to open at several new sites in the next few months. Callisto believes there exists an "unmet medical need" for new treatments for advanced and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. carcinoid tumors because there are no FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved drugs for these types of tumors. Carcinoid tumors, or carcinoids, originate in hormone-producing cells of the gastrointestinal (GI) tract, the respiratory tract respiratory tract n. The air passages from the nose to the pulmonary alveoli, including the pharynx, larynx, trachea, and bronchi. 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 small intestine Long, narrow, convoluted tube in which most digestion takes place. It extends 22–25 ft (6.7–7.6 m), from the stomach to the large intestine. . "The exciting results from the Phase I/IIa trial of Atiprimod in advanced cancer patients have transformed our Atiprimod development program," said Dr. Gary S. Jacob, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Callisto. "The study uncovered a patient population with carcinoid tumors that could potentially benefit from our drug, and our intention is to move aggressively forward with further clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of Atiprimod in a larger population of carcinoid patients." In particular, Atiprimod may provide new hope for patients with advanced carcinoid tumors of the liver and GI tract. Common sites of carcinoid metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma include liver, lungs, bone and lymph nodes. Carcinoid tumors that metastasize me·tas·ta·size v. To be transmitted or transferred by or as if by metastasis. Metastasize Spread of cells from the original site of the cancer to other parts of the body where secondary tumors are formed. 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. "Atiprimod is a drug that we know from tissue distribution studies accumulates at highest concentrations in liver and the gastrointestinal tract," noted Dr. Donald Picker, Executive VP of Research & Development. "Because of this response, we are now focusing on a range of other liver cancers and other metastatic diseases in addition to carcinoids. We are very excited to initiate a formal separate carcinoid clinical trial for this serious disease, where there are no currently approved drugs for these liver metastatic patients." The earlier Atiprimod trial in advanced cancer patients at the University of Texas M. D. Anderson Cancer Center entitled: "An Open Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients with Advanced Cancer" which was begun in March, 2005, originally was designed to assess Atiprimod's activity in solid tumors and hematologic malignancies. 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 acute lymphocytic leukemia n. See acute lymphoblastic leukemia. acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults 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 staphylococcus (stăf'ələkŏk`əs), any of the pathogenic bacteria, parasitic to humans, that belong to the genus Staphylococcus. The spherical bacterial cells (cocci) typically occur in irregular clusters [Gr. and Streptococcus streptococcus (strĕp'təkŏk`əs), any of a group of gram-positive bacteria, genus Streptococcus, some of which cause disease. 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 Frankfurt Stock Exchange The largest of Germany's eight securities exchanges, operated by Deutsche Borse AS. 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. |
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