Submitted by Armen Hareyan on Jun 25th, 2007
Carcinoid Cancer
Callisto Pharmaceuticals announced the addition of a clinical site to its Phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendocrine carcinoma (advanced carcinoid cancer).
The additional site is the Scott & White Memorial Hospital, Scott Sherwood and Brindley Foundation, 2401 South 31st Street, Temple, TX 76508. The principal investigator for the Scott & White Memorial Hospital is Arthur Frankel, M.D.
"The addition of this major cancer 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. "This site is active in the treatment of neuroendocrine cancers, which should substantially enhance the pace of enrollment and increased accessibility to prospective patients interested in participating in this trial." Currently Callisto has enrolled 23 patients of the 40 subjects planned for this Phase II clinical 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 twoweeks 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.
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.
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.
Source:
Callisto Pharmaceuticals, Inc. 