Here is a story about the start of an important Phase 2 trial we found on Pharmaceutical Business Review yesterday:

CytRx Begins Bafetinib Phase 2 Clinical Trial
Published: 31-May-2010

CytRx, a biopharmaceutical company specialising in oncology, has initiated Phase 2 clinical trial to assess the preliminary efficacy and safety of Bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL).
CytRx said that 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.

In this Phase 2 clinical trial, high-risk B-CLL patients who have failed treatment with first-line agents are expected to self-administer oral doses of Bafetinib twice daily. The Bafetinib dose used in this trial is based on the highest tolerated dose in a Phase 1 study.

In the trial, the patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Enrollment is expected to be completed in 12 to 14 months, with potential interim data announcements periodically.

Steven Kriegsman president and CEO of CytRx, said: “This is the first of six Phase 2 clinical trials we plan to initiate this year with our promising oncology candidates Bafetinib and INNO-206 and, importantly, marks a major milestone in our evolution as an oncology company.

“Our strategy is to conduct small studies and, based on the success of these trials, further determine efficacy by quickly moving into larger comparative trials either using our internal resources or with partners. This strategy reflects our goals of rapidly advancing our oncology pipeline toward commercialization and enhancing shareholder value.”

Daniel Levitt, chief medical officer of CytRx, said: “We are cleared to begin recruiting patients for this trial at the MD Anderson Cancer Center in Houston. Patients with advanced-stage, high-risk B-CLL may benefit from Bafetinib’s dual protein kinase inhibition mechanism and, more specifically, from its ability to inhibit Lyn kinase.

“Bafetinib has shown significant activity in blocking B-CLL proliferation in vitro and has demonstrated anti-tumor activity in patients with chronic myelogenous leukemia, who have failed first- and second-line therapy with the approved bcr/abl kinase inhibitors, Gleevec, Sprycel and Tasigna. We also are preparing to commence Phase 2 clinical testing with Bafetinib in glioblastoma multiforme.”

Let’s hope this stuff works! Interesting that it is an oral medication. Feel good and keep smiling! Pat & Pattie

Leave a Reply