CALLISTO BEGINS NEUROENDOCRINE CARCINOMA TRIAL

Callisto Pharmaceuticals has announced the initiation of a multicenter, open-label, Phase II clinical trial of Atiprimod to treat low- to intermediate-grade neuroendocrine carcinomas including advanced carcinoid cancers.

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 either symptoms, despite standard therapy (octreotide), or progression of neuroendocrine tumors. A maximum of 40 evaluable patients will be enrolled in this trial. Efficacy evaluations will include the measure of target lesions and the quantization of symptom relief.

Atiprimod is an orally bioavailable, 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 three clinical trials: a Phase II trial in advanced carcinoid cancer patients, a Phase I/IIa trial in relapsed or refractory multiple myeloma patients and a Phase I/IIa trial in advanced cancer patients. Callisto announced in June interim data from the 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 standard therapies. During treatment, three of the five advanced carcinoid patients had measurable tumor regressions.