Callisto starts dosing in Ph I L-annamycin trial

Callisto Pharmaceuticals, a New York, USA-based developer of new drug treatments in the fight against cancer and other major health threats, has commenced dosing of a patient in a Phase I clinical trial of L-annamycin in children and young adults with refractory or relapsed acute lymphocytic leukemia or acute myelogenous leukemia at The Children's Hospital, Denver, Colorado, where the principal investigator is Lia Gore.

The study utilizes the Pediatric Oncology Experimental Therapeutics Investigators Consortium, a group of prestigious pediatric cancer centers that focuses on early clinical development of promising therapies for the treatment of children, adolescents and young adults with cancer.

The primary objectives of the Phase I clinical trial are: to evaluate safety and identify the maximum tolerated dose of L-annamycin, starting at 130mg/m2/day, given over three consecutive days, and escalating in sequential cohorts until an MTD is reached; and to evaluate the antileukemia activity of the agent in children and young adults with refractory or relapsed ALL or AML. The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol. The product is administered by infusion using a unique patented liposomal formulation.