Callisto Pharmaceuticals Clinical Study of Anti-Leukemia Drug L-Annamycin Expanded to an Additional Clinical Site; Montefiore Medical Center Commences Enrollment of Adult Leukemia Patients in Phase I/IIa Clinical Trial.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 the expansion of its ongoing Phase I/IIa clinical trial of L-Annamycin to treat adult patients with relapsed or refractory 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 (ALL), to an additional clinical trial site, the Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. , Bronx, NY, a leading cancer research center in the U.S. The first patient at Montefiore was enrolled on March 7, 2006 under the direction of Dr. Samir Parekh, the principal investigator at Montefiore Medical Center. "We are pleased to announce the addition of the Montefiore Medical Center as a clinical site for Callisto's evaluation of L-Annamycin to treat Acute Lymphocytic Leukemia, a serious cancer of the blood," said Dr. Donald Picker, Callisto's Executive Vice President of Research and Development. "Montefiore Medical Center is a preeminent institution for the study of cancer, and we are very gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. that this site has joined the clinical trial of L-Annamycin, providing an additional pool of potential patients for the present study." In previous published animal studies, L-Annamycin has demonstrated that it can kill tumor cells that are resistant to other anthracycline anticancer drugs Anticancer Drugs Definition Anticancer, or antineoplastic, drugs are used to treat malignancies, or cancerous growths. Drug therapy may be used alone, or in combination with other treatments such as surgery or radiation therapy. . In addition, earlier studies have shown that L-Annamycin may have other key advantages over other anthracycline drugs, including a decreased risk of treatment-related cardiomyopathy Cardiomyopathy Definition Cardiomyopathy is a chronic disease of the heart muscle (myocardium), in which the muscle is abnormally enlarged, thickened, and/or stiffened. (inflammation of the heart muscle), a complication associated with this family of anticancer drugs. Callisto additionally plans to evaluate L-Annamycin for the treatment of children with refractory or relapsed ALL, and refractory or relapsed acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. (AML AML - A Manufacturing Language ), respectively, as well as in the treatment of adults with relapsed or refractory AML in combination with Ara-C. Callisto intends to begin separate clinical trials in these populations in 2006. If these trials are successful, an even broader population of leukemia patients could benefit from L-Annamycin. The clinical trial to evaluate L-Annamycin in relapsed or refractory ALL was initiated in December, 2005 at the University of Texas M. D. Anderson Cancer Center, in Houston, Texas, where it remains ongoing. L-Annamycin is one of two anticancer drugs in development by Callisto that has received Orphan Drug designation by the 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. . This designation guarantees that after FDA approval of the drug, the sponsoring company has marketing exclusivity within the United States for seven years following commercial launch. The FDA's Orphan drug designation also provides significant additional benefits to the sponsoring company, including eligibility for research grants and protocol assistance, opportunities for regulatory agency assistance on review of clinical protocols, and waiver of the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ) filing fee. About Montefiore Medical Center Montefiore excels at supporting, nurturing and guiding patients on every level during their fight with cancer. As a National Cancer Institute-designated research center, Montefiore is a national leader in the field of Oncology. Montefiore works tirelessly to translate new findings into improved patient care and successful treatment outcomes as swiftly and effectively as possible. Montefiore pledges to give patients access to the most potentially effective treatment regimes available. For more information visit: http://www.montefiore.org/services/coe/cancer/ 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 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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