Callisto reports positive interim data from Phase II carcinoma trial

In this interim analysis, 25 of 46 enrolled patients had sufficient data available for evaluation. The median follow up of the patients was six months (range two to over 12 months). All patients enrolled in this study had evidence of progressing disease in the six months preceding enrollment.

Of the evaluable patients in the tumor response analysis, 92% had stable disease as best response per standard Recist criteria, with a median duration of six months. Actuarial progression free survival at six months is 76% and at 12 months it is 50%. There were no objective Recist responses for tumor regression in the analyzed cohort.

In symptom relief analysis, 17 patients were evaluable for relief of symptoms of carcinoid cancer (flushing, wheezing, diarrhea), of which 82% of patients responded with at least one treatment cycles daily average frequency of at least one symptom that was reduced by 20% or more from the screening daily average for that symptom, as recorded by the patients in a daily diary. Overall, the interim results suggest that Atiprimod is an active and well tolerated drug in the treatment of carcinoid cancer.

Gary Jacob, CEO of Callisto, said: “Importantly, in this slow growing cancer, Atiprimod has shown an ability to stabilize disease progression and to reduce the symptoms of this disease, with a side effect profile that is generally well tolerated, with reversible increases in liver transaminases as the most notable adverse event.”