CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies demonstrating that its oncology drug candidate bafetinib inhibits bone destruction in model systems is being presented on April 2, 2011 at the American Academy for Cancer Research (AACR) 102 nd Annual Meeting in Orlando, Florida. Dr. James R. Berenson, Medical & Scientific Director of the Institute for Myeloma & Bone Cancer Research, commented, “As recently reported, our research shows that bafetinib, even in low concentrations, significantly inhibited the cells that cause bone destruction that can lead to devastating consequences in cancer patients such as fractures, bone pain and hypercalcemia. I believe that bafetinib certainly warrants additional study in this area.” The abstract, titled “The tyrosine kinase inhibitor bafetinib (INNO-406) inhibits osteoclast formation and bone resorption,” is based on a series of preclinical studies evaluating the effect of bafetinib on bone cells (osteoclasts) from multiple myeloma patients. Osteoclasts are multinucleated bone-resorbing cells derived from monocytes that play critical roles in bone remodeling. Prior studies indicated that Lyn and Fyn kinases have negative impacts on osteoclasts, thus potentially reducing bone resorption. Bafetinib is an inhibitor of Bcr-Abl, Fyn and Lyn kinases, which prompted these initial studies in bone loss and bone resorption. To evaluate the effects of bafetinib on osteoclast formation and bone resorption, monocytes derived from multiple myeloma patients and normal subjects were stimulated to form osteoclasts and at the same time were treated with bafetinib. As a parallel, the same type of cells were treated with zoledronic acid (Zometa), an inhibitor of osteoclast formation and bone resorption currently used to prevent skeletal complications for patients with multiple myeloma, metastatic bone diseases or osteoporosis. Bafetinib and zoledronic acid both markedly inhibited osteoclast cell formation at similar concentrations in both multiple myeloma and normal monocytes. An additional in vitro study demonstrated that bafetinib reduced osteoclast formation by blocking the pathway leading to monocyte transformation. In other experiments, bafetinib, even at low concentrations, significantly inhibited bone resorption in a concentration-dependent fashion. CytRx President and CEO Steven A. Kriegsman said, “We see a significant opportunity with bafetinib’s ability to block several of the kinases involved in bone resorption as well as cancer cell growth. Several cancers have a high incidence of bone metastases, and bafetinib may be an important therapy, either alone or in combination with other agents, to treat theses types of tumors.”
CytRx is currently evaluating bafetinib in three ongoing clinical trials: 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; a pharmacokinetic clinical trial in patients with recurrent brain tumors; and the PROACT Phase 2 proof-of-concept prostate cancer clinical trial in patients with advanced prostate cancer.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), a pharmacokinetic clinical trial in brain cancer and the PROACT Phase 2 clinical trial in advanced prostate cancer. With its tumor-targeting pro-drug candidate INNO-206, CytRx is conducting a safety trial with plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for soft tissue sarcomas and pancreatic cancer. 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.