NEW YORK, Sept. 20 Callisto Pharmaceuticals,Inc. (Amex: KAL; FWB: CA4), a developer of new drug treatments in the fightagainst cancer and gastrointestinal disorders and diseases, announced todaythat complete enrollment of its Phase II clinical trial of Atiprimod to treatlow to intermediate grade neuroendocrine carcinoma (advanced carcinoid cancer)was accomplished ahead of schedule. The trial, designed to enroll 40patients, presently has patients enrolled at seven clinical sites in the U.S.,and was closed to further enrollment with the addition of the 40th patient.
"This Atiprimod trial was initiated in November, 2006 and we are pleasedwith the tremendous pace of enrollment that we experienced," said Dr. Gary S.Jacob, Chief Executive Officer of Callisto. "We have patients who have nowbeen on our drug for as long as 11 months, and we expect that by January of2008 the bulk of patients will have been treated for 6 months or more on ourdrug. We anticipate at that time releasing interim data from the trial aswell as planning for a meeting with FDA on the design of a registrationtrial."
The primary objective of the Phase II clinical trial was to evaluateefficacy of Atiprimod in patients with low to intermediate gradeneuroendocrine carcinoma who have metastatic or unresectable cancer and whohave progression of their disease despite standard therapy (octreotide).Patients, after signing an informed consent, were required to complete twoweeks of a symptoms diary to establish their symptoms baseline beforecommencing Atiprimod dosing. Efficacy evaluations include the measure oftarget lesions (per RECIST), and the quantization of symptom relief. Furtherdetails of this trial can be found at http://www.clinicaltrials.gov.
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 in twoclinical trials: a Phase II trial in advanced carcinoid cancer patients, and aPhase I/IIa human clinical trial in relapsed or refractory multiple myelomapatients. Callisto earlier announced in June, 2006 interim data from a Phase Itrial of Atiprimod in advanced cancer patients. The patients who were enteredinto this trial had growing tumors and symptoms that were no longer controlledby the standard therapies utilized. During treatment, three of the fiveadvanced carcinoid patients had measurable tumor regressions and loss of manyof 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 past 20-30years. Carcinoid tumors that metastasize to the liver have a poor prognosis.Traditionally, chemotherapy relieves symptoms in less than 30% of cases ofmetastatic carcinoid tumors, usually for less than 1 year. Carcinoid tumorstypically produce a condition called "carcinoid syndrome" which is caused bythe release of hormones by the tumors into the blood stream. The symptoms varydepending on which hormones are released by the tumors, but typically includediarrhea, facial flushing, wheezing, abdominal pain and valvular heartdisease.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development of newdrugs to treat various forms of cancer and