CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer. The open-label PROACT trial is being conducted at City of Hope, located just outside of Los Angeles, California, as well as multiple clinical sites in India. In the trial, approximately 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with chemotherapy will receive orally available bafetinib twice daily. The trial endpoints are reduction in prostate-specific antibodies and increases in progression-free survival compared to baseline and historical data. “We are truly delighted to be working with City of Hope, an institution that is recognized by the National Cancer Institute for its excellence in cancer research, treatment and education,” said Steven A. Kriegsman, CytRx President and CEO. “The treatment of hormone-refractory prostate cancer has been unsatisfactory with currently approved treatments involving substantial toxicity and extending survival by only a few months. An agent that could prevent growth of advanced-stage prostate cancer with reduced side effects could provide a significant quality-of-life improvement and represent a giant step forward in the treatment of this disease. Bafetinib has the potential to be such a drug.” CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D., stated, "Bafetinib is a dual protein kinase inhibitor targeting both Bcr/Abl and Lyn kinases. Hormone-refractory prostate tumor specimens overexpress Lyn kinase compared to prostatic tumor samples from the same individuals taken before hormone-deprivation therapy. This suggests that Lyn kinase may be required for tumor cell growth and progression. Thus the administration of bafetinib, which inhibits Lyn kinase, may stop the growth of hormone-refractive prostate cancer.” CytRx is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer and plans to begin a Phase 1 trial in brain cancer shortly.
Prostate cancer is the second most common malignancy and second-leading cause of cancer death among American men, according to the American Cancer Society. Of those diagnosed, one in 35 men will die of prostate cancer. The National Cancer Institute estimates that more than 217,000 new cases and more than 32,000 deaths will be attributed to prostate cancer in the U.S. this year. Treatment of the disease can vary significantly from watchful waiting to surgery, radiation or both, followed by hormonal treatment. Hormonal treatment can shrink the cancer, delay its growth and reduce symptoms; however, patients with metastatic prostate cancer usually stop responding to this therapy within two years. The disease at this stage, called metastatic hormone-refractory prostate cancer, is typically treated with chemotherapeutic agents, and patients have a median survival period of less than two years, according to the National Cancer Institute.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: bafetinib, tamibarotene and INNO-206. CytRx has 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 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 17% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit http://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 trials for bafetinib, including for prostate cancer, B-CLL and brain cancer, 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 prostate cancer, B-CLL and brain cancer, the risk that any future human testing of bafetinib for prostate cancer, B –CLL and brain cancer 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.