– Patent Provides Broad Intellectual Property Protection into 2025 –
– Phase 2 Clinical Trial Underway with Bafetinib in B-cell Chronic Lymphocytic Leukemia; Two Additional Bafetinib Trials Planned to Commence in 2010 –
LOS ANGELES--(BUSINESS WIRE)-- 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 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.”
CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. 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 November 2008, CytRx announced that bafetinib demonstrated clinical responses in patients with CML in an international, open-label Phase 1 dose-ranging clinical trial conducted in patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec and, in some cases, second-line tyrosine kinase inhibitors such as dasatinib and nilotinib. In April 2010, the Company announced that bafetinib had received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product status for the treatment of chronic myeloid leukemia (CML). Bafetinib also has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the U.S. Food and Drug Administration (FDA).
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, bafetinib and tamibarotene. CytRx recently announced plans to initiate three Phase 2 clinical trials with its oncology candidate INNO-206 as a treatment for pancreatic cancer, gastric cancer and soft tissue sarcomas. In May 2010, the Company announced initiation of a Phase 2 clinical trial with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL). CytRx also plans to initiate Phase 2 clinical trials in glioblastoma multiforme (a common and aggressive type of primary brain tumor) and advanced prostate cancer. In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 28% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit http://www.cytrx.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the outcome, timing and results of CytRx's Phase 2 clinical testing for bafetinib, uncertainties regarding regulatory approvals for current and future clinical testing of bafetinib and the scope of the clinical testing that may eventually be required by regulatory authorities for bafetinib, uncertainties related to the enforcement of United States patents, the significant time and expense that will be incurred in developing any of the potential commercial applications for bafetinib, including for B-CLL, the risk that any future human testing of bafetinib might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture its drug candidates, including bafetinib, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of bafetinib, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Legend Securities, Inc.
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical