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news.CytRx has planned to initiate a phase 2 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).
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Reportedly, in the planned phase 2 trial, approximately 20 patients who have failed treatment with first-line agents will be administered daily oral doses of Bafetinib. In the study, the 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.
Steven Kriegsman, president and CEO of CytRx, said: “We believe Bafetinib is a treatment that could be efficacious in a wide range of hematological cancers. Our objective is to evaluate results from this trial, and if successful, quickly progress into later-stage clinical trials either internally or with partners. An effective treatment could result in a multi-billion dollar oncology product for CytRx.”
Daniel Levitt, chief medical officer of CytRx, said: “We are optimistic that our 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. Bafetinib has shown activity in blocking B-CLL cell proliferation in-vitro and caused increased cancer cell death. Additionally, Bafetinib has demonstrated anti-tumor activity in patients with chronic myelogenous leukemia, who have failed first- and second-line therapy with other kinase inhibitors.”