CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced the granting by the U.S. Patent and Trademark Office (USPTO) of U.S. Patent 7,728,131 for oncology drug candidate bafetinib, encompassing 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. The Issue Notification for the patent, which has a September 2025 expiration date, was received by CytRx's licensor, Nippon Shinyaku Co., LTD. CytRx holds the exclusive rights to bafetinib in all indications in the U.S. and throughout the world, with the exception of Japan.
“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.”
"This broad U.S. 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," said CytRx President and CEO Steven A. Kriegsman. "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."
In May 2010, CytRx announced the initiation of a Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). B-CLL is the most common form of leukemia in adults in Western countries. Additional Phase 2 proof-of-concept trials with bafetinib in glioblastoma multiforme - a common and aggressive type of primary brain tumor - and in advanced prostate cancer are planned to commence later this year.
"The USPTO has recognized that bafetinib is a unique compound, which is especially useful for being a novel combination of Bcr-Abl and Lyn kinase inhibitors," said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. "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. Lyn kinase is over expressed in B-CLL, hormone-refractory prostate cancer, glioblastoma multiforme, Ewing's sarcoma and acute myeloid leukemia (AML). 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."