CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced initiation of a Phase 2 proof-of-concept clinical trial to evaluate the preliminary efficacy and safety of its oncology drug candidate bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL). “This is the first of six Phase 2 proof-of-concept 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,” said CytRx President and CEO Steven A. Kriegsman. “Our strategy is to conduct small proof-of-concept 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.” In this Phase 2 proof-of-concept clinical trial, high-risk B-CLL patients who have failed treatment with first-line agents will 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 led by the University of Texas MD Anderson Cancer Center in Houston. 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. “We are cleared to begin recruiting patients for this trial at the MD Anderson Cancer Center in Houston,” said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. “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 – an enzyme that is over-expressed in certain cancers including B-CLL. 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 – a common and aggressive type of primary brain tumor – and advanced hormone-refractory prostate cancer.” Leukemias are cancers of the while blood cells. B-CLL involves an abnormal and malignant proliferation of a particular subtype of white blood cells known as B cells, which originate in the bone marrow, migrate to the lymph nodes and spleen, and normally fight infection by producing antibodies. In B-CLL, the DNA of a B cell is damaged, causing a single damaged B cell to proliferate and accumulate in the bone marrow and blood, crowding out healthy blood cells.
B-CLL is the most common form of leukemia in adults in Western countries. More than 17,000 new cases of B-CLL are reported in the United States each year; however up to an estimated 40% of cases may not be reported due to under-diagnosis and lack of placement in cancer registries. Virtually all patients are older than 55 years at presentation, with an average age of 70 years. Patients with high-risk B-CLL who have failed other therapies have a median overall survival of one to five years.About Bafetinib 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, including INNO-206, bafetinib and tamibarotene. CytRx recently announced plans to initiate Phase 2 clinical trials with its oncology candidate INNO-206 as a treatment for pancreatic cancer, gastric cancer and soft tissue sarcomas. The Company also has announced plans to initiate three Phase 2 clinical trials with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL), 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 www.cytrx.com. Forward-Looking Statements 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 trial for bafetinib for B-CLL, 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, 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 for B-CLL 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.