FDAnews
www.fdanews.com/articles/72316-hana-biosciences-initiates-phase-i-ii-trial-of-talotrexin

Hana Biosciences Initiates Phase I/II Trial of Talotrexin

May 13, 2005

Hana Biosciences has initiated a Phase I/II clinical study of talotrexin (PT-523) as a single agent in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

The Phase I portion of this multicenter study will determine the dose, safety, tolerability and pharmacokinetics of talotrexin in refractory leukemia patients, including both myeloid and lymphoid leukemias. The Phase II component will focus on relapsed or refractory ALL patients to determine the efficacy of talotrexin, as measured by complete response rate.