CytRx Corporation (Nasdaq:CYTR) a biopharmaceutical company specializing in oncology, today announced initiation of a pharmacokinetic clinical trial with its oncology drug candidate bafetinib in patients with recurrent brain tumors. Results from this trial are expected in the second quarter of 2011 and will be used in evaluating potential further clinical development of bafetinib in patients with brain cancer. Six to eight patients with recurrent primary brain cancer or recurrent brain metastases who have undergone brain surgery will be evaluated in the trial, which is being conducted at City of Hope Cancer Center in the U.S. The trial’s primary objective is to provide neuropharmacokinetic information, such as the ability of bafetinib to cross the blood:brain barrier and the percentage that enters the brain compared to the amount in systemic blood. In addition to the announced clinical trial in patients with brain cancer, the Company has already initiated enrollment of patients in both its PROACT Phase 2 proof-of-concept prostate cancer clinical trial evaluating the efficacy and safety of bafetinib in patients with advanced cancers, and its ENABLE clinical trial in patients with a late-stage form of leukemia known as high-risk B-cell chronic lymphocytic leukemia, or B-CLL. "This rapid clinical trial is designed to provide proof of bafetinib’s ability to cross the blood:brain barrier, verifying results from prior animal studies. It is essential that bafetinib cross this natural protective barrier in pursuing brain cancer,” said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. “This trial also will allow us to gain initial experience in terms of bafetinib’s tolerability at the dose under consideration for possible future testing in patients with brain cancer. “Lyn kinase is overexpressed in biopsy samples of glioblastoma multiforme, the most common adult brain tumor, which suggests that Lyn kinase may be required for tumor cell growth and progression. As a result, we believe that the administration of bafetinib, which inhibits Lyn kinase, may stop the growth of brain cancer,” Dr. Levitt added.
Steven A. Kriegsman, CytRx President and CEO, said, “This is another important step in our strategy to advance clinical development of bafetinib in brain cancer either with internal resources or through a strategic alliance. New treatments for the management of primary and metastatic brain malignancies are urgently needed. The approval of targeted anti-cancer therapies in recent years has resulted in improved survival rates for many patients with solid tumors outside the brain; however, it is becoming more common for those cancer patients to suffer from metastatic disease to their brains.About Brain Cancer Brain tumors can be benign, with no cancer cells, or malignant, with cancer cells that grow quickly. There are two main types of brain cancer. Primary brain cancer, or glioma, starts in the brain and metastatic brain cancer starts somewhere else in the body and moves to the brain. Gliomas represent approximately 70% of the 22,500 malignant primary brain tumors diagnosed annually in American adults. Glioblastoma, the most common type of glioma in adults, is incurable with median overall survival of 12-15 months. 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. The Company 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 is conducting a pharmacokinetic clinical trial in brain cancer. With its tumor-targeting pro-drug candidate INNO-206, CytRx plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for pancreatic cancer and soft tissue sarcomas, following an abbreviated safety trial. 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 pharmacokinetic clinical trial of bafetinib in patients with 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 brain cancer, the risk that any future human testing of bafetinib for 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.