Bafetinib is an 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.
CytRx said that the received patent encompasses claims related to Bafetinib’s pharmaceutical compound and composition in all indications, as well as for use in methods for treating acute and chronic myelogenous leukemia and acute lymphoblastic leukemia.
CytRx holds the exclusive rights to Bafetinib in all indications in the US and throughout the world, with the exception of Japan.
Earlier, in May 2010, CytRx had initiated a Phase 2 clinical trial to evaluate the efficacy and safety of Bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). Additional Phase 2 trials with Bafetinib in glioblastoma multiforme and in advanced prostate cancer are planned to commence later this year.
Steven Kriegsman, president and CEO of CytRx, said: “This broad US patent covering the composition of Bafetinib supports our investment in advancing Bafetinib’s clinical development, and is an exciting strategic element in our ultimate goal of commercialization.
“This patent provides significant intellectual property protection for our current clinical programs in leukemia, brain cancer and prostate cancer, and bolsters our planned evaluation of Bafetinib as a treatment in multiple additional oncology indications.”
Daniel Levitt, chief medical officer of CytRx, said: “The USPTO has recognised that Bafetinib is a unique compound, which is especially useful for being a novel combination of Bcr-Abl and Lyn kinase inhibitors.
“The key differentiator of Bafetinib over other currently approved tyrosine kinase inhibitors, such as Gleevec, Sprycel and Tasigna, is its ability as a potent inhibitor of Lyn kinase. Bafetinib has shown significant activity in blocking B-CLL proliferation in vitro and anti-tumor activity in patients with chronic myelogenous leukemia, who have failed first- and second-line therapy.”