CALLISTO BEGINS PEDIATRIC TRIAL OF LEUKEMIA TREATMENT

Callisto Pharmaceuticals has begun a multicenter, open-label, dose-escalation Phase I clinical trial of L-Annamycin in children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML).

The primary objectives of the Phase I clinical trial are to evaluate safety and identify the maximum tolerated dose (MTD) of L-Annamycin, starting at 130 mg/m2/day, given over three consecutive days, and escalating in sequential cohorts until an MTD is reached, as well as to evaluate the antileukemia activity of L-Annamycin. The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol. L-Annamycin is administered by infusion using a unique patented liposomal formulation.

"We are particularly interested in exploring the potential of L-Annamycin to treat children and young adults with acute leukemia," Gary Jacob, CEO of Callisto, said. "L-Annamycin is presently in a Phase I clinical trial in adult relapsed or refractory ALL patients, and we have gained important experience with this drug in the adult setting that we hope to apply to the pediatric trial."

In preclinical studies, L-Annamycin has been shown to circumvent multidrug resistance and to have decreased cardiotoxicity. The drug was granted FDA orphan drug designation for treating both ALL and AML in June 2005.