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Phase 2 Study Initiated of Xanafide in Combination with ara-C for Treatment Of Secondary AML
"Currently, there are no approved therapies specifically indicated for secondary AML, a disease that responds infrequently and only briefly to standard therapies," said Robert L. Capizzi, M.D., Xanthus' Chief Medical Officer. "We are extremely encouraged by the 46% response rate achieved in the Phase 1 trial of amonafide and ara-C in patients with AML, together with the acceptable safety profile, given that the vast majority of enrollees in this phase 2 trial are likely to be elderly, with high-risk AML."
About the Phase 2 study
The Phase 2 study will be conducted at multiple centers in North America and is expected to enroll up to 60 patients with secondary AML (patients with antecedent myelodysplastic syndrome or prior exposure to leukemogenic therapy). Patients will receive a daily dose of Xanafide for five days in combination with a standard dose of ara-C as a continuous infusion for 7 days. The primary endpoint of the study is the rate of complete remission, and secondary endpoints include duration of remission and overall survival.
Xanafide (amonafide malate) is an ATP-independent topoisomerase 2 inhibitor. In a Phase 1 study, amonafide and ara-C in patients with poor-risk AML demonstrated a clinical response rate of 46% (12/26), with 38% (10/26) achieving complete remission and two patients achieving near-complete remission. The median duration of remission was five months, with two patients remaining disease-free for over two years and over 5 years following post remission therapy. Results of this Phase 1 study were presented at the 2005 ASCO annual meeting.
Source: Xanthus Life Sciences