CytRx to conduct Phase II trial with bafetinib in B-CLL.
M2 EUROPHARMA-(C)1999-2010 M2 COMMUNICATIONS
15 January 2010 - US-based biopharmaceutical company CytRx Corporation (NASDAQ:CYTR) said on Wednesday it plans to initiate a Phase II proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib (formerly known as INNO-406) in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL).
Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, which is currently being planned as a third-line treatment for patients with chronic myeloid leukemia (CML) or certain forms of acute myeloid leukemia (AML) that are refractory or intolerant of other approved treatments.
In the planned Phase II trial, approximately 20 patients who have failed treatment with first-line agents will be administered daily oral doses of bafetinib. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Based on trial results, CytRx plans to conduct a larger comparative trial to further determine efficacy of this agent.
According to Daniel Levitt, CytRx chief medical officer, the company is optimistic that its dual protein kinase inhibitor bafetinib will demonstrate efficacy in patients with high-risk B-CLL who have failed other therapies and have few viable treatment options.
B-CLL is the most common form of leukemia in adults in western countries. More than 17,000 new cases of B-CLL are reported in USA each year.