"In this trial, telotristat etiprate provided rapid and durable benefit across several dimensions of carcinoid syndrome, a devastating metastatic cancer syndrome with few treatment options for patients," said Dr. Pablo Lapuerta, Lexicon's senior vice president and chief medical officer. "Of additional interest was improvement seen in two patients who were not on background somatostatin analog therapy, the only currently-approved treatment."The open-label, dose-escalation study was conducted in Europe in 15 patients with metastatic carcinoid syndrome who were refractory to or could not tolerate somatostatin analog therapy. Efficacy measures included change in bowel movement frequency, relief of symptoms, and reduction in serotonin synthesis. Patients received ascending doses of 150 mg, 250 mg, 350 mg and 500 mg of telotristat etiprate, administered three times daily (TID), for 14 days on each dose until reaching a maximal dose, which was then continued until the completion of 12 weeks of therapy. Escalation to a higher dose was contingent on tolerability and clinical response. Fourteen patients (93%) completed the trial, and 12 of these 14 patients were treated with 500 mg TID of study drug during the last four weeks of the treatment period. The one patient who discontinued early withdrew from the 350mg TID dose level for reasons not related to drug safety. Notably, the two patients in the study who were not receiving background somatostatin analog therapy observed reductions in bowel movements of 67% and 48% from baseline to week 12.
Second Phase 2 Trial Of Telotristat Etiprate Shows Positive Results In Carcinoid Syndrome
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