Callisto Announces Details of Upcoming Trial of Annamycin

Callisto Pharmaceuticals has announced further details of its planned trial of Annamycin in adults with relapsed/refractory acute lymphoblastic leukemia (ALL) patients planned to begin in mid-2005.

The earlier Phase I trial of Annamycin performed in acute leukemia patients by a prior sponsor was recently subjected to a careful audit by Callisto of efficacy and safety data.

Based on this review, the company plans to include in the next trial with Annamycin in adult relapsed/refractory ALL patients an initial evaluation of a small number of patients (two cohorts totaling approximately six patients) to reconfirm the initial safety data in a Phase I/IIa trial that will then be rolled into a larger Phase IIb trial.