CytRx announced initiation of a Phase 2 proof-of-concept clinical trial to evaluate the preliminary efficacy and safety of bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). In this Phase 2 study, high-risk B-CLL patients who have failed treatment with first-line agents will self-administer oral doses of bafetinib twice daily. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival.
Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn kinase inhibitor, which was developed as a third-line treatment for patients with CML and certain forms of acute myeloid leukemia (AML) that are refractory or intolerant of other approved treatments. Additionally, bafetinib has demonstrated clinical responses in patients with CML in an international, open-label Phase 1 dose-ranging clinical trial conducted in patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec (imatinib, from Novartis) and, in some cases, second-line tyrosine kinase inhibitors such as dasatinib and nilotinib.
For more information call (310) 826-5648 or visit www.cytrx.com.