NEW YORK, November 7 /PRNewswire/ --
- Trial to Evaluate both Tumor Regression and Improvement of Symptoms
Callisto Pharmaceuticals, Inc. (Amex: KAL)(FWB: CA4), a developer of newdrug treatments in the fight against cancer and other major health threats,announced today the first dosing of patients in a multi-center, open-labelPhase II clinical trial of Atiprimod to treat low to intermediate gradeneuroendocrine carcinomas including advanced carcinoid cancers. The firststudy site to enter this trial is the Hematology Oncology Services ofArkansas in Little Rock, Arkansas, under the direction of Brad Baltz, M.D.,the principal investigator. Several major cancer centers are currentlyreviewing the trial protocol and the Company anticipates that these siteswill open in the near future.
The primary objective of the Phase II clinical trial is to evaluateefficacy of Atiprimod in patients with low to intermediate gradeneuroendocrine carcinoma who have metastatic or unresectable cancer and whohave either symptoms, despite standard therapy (octreotide), or progressionof neuroendocrine tumors. Patients, after signing an informed consent, arerequired to complete two weeks of a symptoms diary to establish theirsymptoms baseline before commencing Atiprimod dosing. A maximum of 40evaluable patients will be enrolled in this trial. Efficacy evaluations willinclude the measure of target lesions (per RECIST), and the quantization ofsymptom relief. Further details of this trial can be found atwww.clinicaltrials.gov .
"Advanced carcinoid tumors have proven to be very difficult to treateffectively, and accordingly there are very few options available that offerhope to patients with these late-stage tumors," notes Dr. Gary S. Jacob,Chief Executive Officer of Callisto. "The basis for moving forward with thisPhase II trial with Atiprimod comes from encouraging data observed inpatients with advanced carcinoid tumors enrolled in an earlier Phase I/IIaclinical trial of Atiprimod in advanced cancer."
"An important component of this Atiprimod Phase II trial is theevaluation of not only tumor regression but improvement of the debilitatingsymptoms typically associated with this neuroendocrine cancer," said RobertC. Shepard, M.D. F.A.C.P., Callisto's Chief Medical Officer. "Patients willbe keeping daily diaries to monitor their symptoms. The earlier AtiprimodPhase I/IIa trial with advanced carcinoid patients suggested that this drughas the potential of improving symptom management as well as shrinkingtumors."
About Atiprimod
Atiprimod is an orally bio-available small molecule drug that displaysmultiple mechanisms of action. The drug has been shown to be antiangiogenic,inhibit secretion of VEGF and IL-6, elicit an apoptotic response (programmedcellular death), and inhibit phosphorylation of key kinases involved in tumorprogression and survival including Akt and STAT3. The drug is presently inthree clinical trials: a Phase II trial in advanced carcinoid cancerpatients, a Phase I/IIa human clinical trial in relapsed or refractorymultiple myeloma patients, and in a Phase I/IIa trial in advanced cancerpatients. Callisto earlier announced in June, 2006 interim data from thePhase I trial of Atiprimod in advanced cancer patients. The patients who wereentered into this trial had growing tumors and symptoms that were no longercontrolled by the standard therapies utilized. During treatment, three of thefive advanced carcinoid patients had measurable tumor regressions and loss ofmany of the debilitating symptoms of this disease.
About Carcinoid Cancer
Carcinoid tumors, or carcinoids, originate in hormone-producing cells ofthe gastrointestinal (GI) tract, the respiratory tract, the hepatobiliary(liver) system and the reproductive glands. The most common site of origin isthe GI tract, with tumors often developing in the rectum, and other sectionsof the small intestine. Approximately 7,000 cases of carcinoid cancer arediagnosed in the U.S. annually, with the number increasing over the past20-30 years. Carcinoid tumors that metastasize to the liver have a poorprognosis. Traditionally, chemotherapy relieves symptoms in less than 30% ofcases of metastatic carcinoid tumors, usually for less than 1 year. Carcinoidtumors typically produce a condition called "carcinoid syndrome" which iscaused by the release of hormones by the tumors into the blood stream. Thesymptoms vary depending on which hormones are released by the tumors, buttypically include diarrhea, facial flushing, wheezing, abdominal pain andvalvular heart disease.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development of newdrugs to treat various forms of cancer and other serious afflictions.Callisto's drug candidates in development currently include anti-canceragents in clinical development, in addition to drugs in pre-clinicaldevelopment for other significant health care markets, including ulcerativecolitis. One of the Company's lead drug candidates, Atiprimod, is indevelopment to treat advanced carcinoid cancer, a neuroendocrine tumor, andrelapsed multiple myeloma, a blood cancer. Atiprimod is presently in a PhaseII clinical trial in advanced carcinoid cancer patients, and in Phase I/IIahuman clinical trials in relapsed multiple myeloma patients, and advancedcancer patients, respectively. Another anti-cancer drug, L-Annamycin, isbeing developed as a treatment for forms of relapsed acute leukemia, acurrently incurable blood cancer. Callisto initiated a clinical trial ofL-Annamycin in adult relapsed acute lymphocytic leukemia patients in 4Q 2005.L-Annamycin, a new compound from the anthracycline family of provenanti-cancer drugs, has a novel therapeutic profile, including activityagainst resistant diseases and significantly reduced cardiotoxicity, ordamage to the heart, compared to currently available drug alternatives.Callisto also has drugs in preclinical development for gastro-intestinalinflammation, and cancer. Callisto has exclusive worldwide licenses fromAnorMED Inc. and M.D. Anderson Cancer Center to develop, manufacture, use andsell Atiprimod and L-Annamycin, respectively. Callisto is also listed on theFrankfurt Stock Exchange under the ticker symbol CA4. More information isavailable at http://www.callistopharma.com .
Forward-Looking Statements
Certain statements made in this press release are forward-looking. Suchstatements are indicated by words such as "expect," "should," "anticipate"and similar words indicating uncertainty in facts and figures. AlthoughCallisto believes that the expectations reflected in such forward-lookingstatements are reasonable, it can give no assurance that such expectationsreflected in such forward-looking statements will prove to be correct. Asdiscussed in the Callisto Pharmaceuticals Annual Report on Form 10-K/A forthe year ended December 31, 2005, and other periodic reports, as filed withthe Securities and Exchange Commission, actual results could differmaterially from those projected in the forward-looking statements as a resultof the following factors, among others: uncertainties associated with productdevelopment, the risk that products that appeared promising in early clinicaltrials do not demonstrate efficacy in larger-scale clinical trials, the riskthat Callisto will not obtain approval to market its products, the risksassociated with dependence upon key personnel and the need for additionalfinancing.
Web site: http://www.callistopharma.com http://www.clinicaltrials.gov
Callisto Pharmaceuticals, Inc.
Dan D'Agostino of Callisto Pharmaceuticals, Inc., +1-212-297-0010, ext. 227, dagostino@callistopharma.com
