CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies show that bafetinib may be useful in preventing bone loss in cancer patients who are at high risk for this event. The studies, which evaluated the effect of bafetinib on bone cells (osteoclasts) from multiple myeloma patients, were directed by leading multiple myeloma expert James R. Berenson, MD, Medical & Scientific Director of the Institute for Myeloma & Bone Cancer Research. The studies demonstrated that in two model systems, bafetinib significantly suppressed the activity of osteoclasts and inhibited bone resorption in a dose-dependent manner, which is the process by which bone cells known as osteoclasts break down bone. Bone formation and bone resorption are closely coupled processes involved in the normal remodeling of bone. In patients with bone metastases, increased bone resorption can outpace bone remodeling, causing bone deterioration. Dr. Berenson stated, “The consequences of bone loss in cancer patients due to increased bone resorption can be devastating, including fractures, bone pain and hypercalcemia. Prior studies indicated that Lyn and Fyn kinases have negative impacts on osteoclasts, thus potentially reducing bone resorption, which prompted us to evaluate bafetinib’s osteoclast inhibitory activity in bone deterioration using cells from multiple myeloma patients. We are encouraged by the results.” CytRx President and CEO Steven A. Kriegsman said, “Results from these first-ever studies evaluating bafetinib’s anti-bone resorptive effects showed that this kinase inhibitor could present a new therapeutic option to reduce skeletal complications in cancer patients. Reduction of bone loss represents one of multiple oncology indications in which bafetinib could represent an effective treatment.” CytRx is currently evaluating bafetinib in three ongoing clinical trials: the PROACT Phase 2 proof-of-concept prostate cancer clinical trial in patients with advanced cancers; the ENABLE Phase 2 proof-of-concept clinical trial in patients with a late-stage form of leukemia known as high-risk B-cell chronic lymphocytic leukemia; and a pharmacokinetic clinical trial in patients with recurrent brain tumors.
About BafetinibCytRx 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. CytRx's pipeline also includes tamibarotene, which it is testing in patients with non-small-cell lung cancer and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). 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 relating to the timing, outcome or results of any future pre-clinical or clinical testing of bafetinib as a treatment for cancer-related bone loss or any other indication, the significant time and expense that will be incurred in developing any of the potential commercial applications for bafetinib, including for B-CLL, prostate cancer or brain cancer, 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, 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.