CytRx Announces the Presentation of Favorable Phase 2 Clinical Results with Bafetinib in Relapsed B-Cell Chronic Lymphocytic Leukemia at ASH Conference

LOS ANGELES -- (BUSINESS WIRE) -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that results from the open-label, single-agent Phase 2 ENABLE proof-of-concept clinical trial demonstrate bafetinib’s clinical activity and preliminary safety in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). The results were presented by Tapan Kadia, M.D., Department of Leukemia at the University of Texas, M.D. Anderson Cancer Center, in a poster session at the 2011 American Society of Hematology (ASH^®) Annual Meeting. CytRx also announced that the ENABLE abstract has been selected for inclusion in the Highlights of ASH^® program for presentation in 2012 in ASH meetings in Austin, Orlando, Atlanta, Las Vegas, New York and San Francisco.

Dr. Kadia, the Phase 2 clinical trial’s principal investigator, presented the abstract, “A Pilot Phase II Study of the Lyn Kinase Inhibitor Bafetinib in Patients with Relapsed or Refractory B Cell Chronic Lymphocytic Leukemia.” In addition to Dr. Kadia, abstract authors include Hagop Kantarjan, M.D.; Maria Delioukina, M.D.; Michael Keating, M.D.; William Wierda, M.D.; and Jan Berger, M.D.; as well as CytRx's Chief Medical Officer Daniel Levitt, M.D., Ph.D.; and Senior Vice President of Drug Development Scott Wieland, Ph.D.

“Bafetinib, which is an inhibitor of Lyn kinase, targets a member of the B-cell receptor activation pathway in a manner similar to inhibitors of other tyrosine kinases developed for B-CLL,” said Dr. Kadia. “Results from the ENABLE trial demonstrated evidence of bafetinib’s single-agent activity in a relapsed B-CLL population, and additional clinical evaluation in combination with other agents is warranted.”

Each of the 18 late-stage B-CLL patients enrolled in the ENABLE trial had been treated with and failed between one and six therapies, with a median of three, and 14 of the 18 patients (87%) having unfavorable cytogenetics. Patients were treated with orally administered bafetinib twice daily. Six of 12 (50%) of the evaluable patients achieved 30% or greater shrinkage of the lymph node and spleen, and four of 12 (33%) patients had stable disease. No serious adverse events (SAEs) were observed at the dose of 240 mg twice daily, which is the dose that would likely be used in any future clinical trials in chronic lymphocytic leukemia. Two patients remain in the trial, which is being conducted at the M.D. Anderson Cancer Center and City of Hope Medical Center.

“Bafetinib is 25 to 55 times more potent than the protein-tyrosine kinase inhibitor imatinib against certain BCR-ABL-positive leukemia cell lines and is a potent inhibitor of Lyn kinase, which is over expressed in many imatinib-resistant leukemia cells,” said Dr. Levitt. “As of today, bafetinib has now been administered to 101 human subjects. We have established bafetinib’s clinical activity in B-CLL patients and the dose for moving into any future clinical trials in combination with a cytotoxic agent or monoclonal antibody.”

CytRx President and CEO Steven A. Kriegsman said, “We are pleased that Dr. Kadia, a prominent expert in his field and the clinical trial’s principal investigator, presented the Phase 2 ENABLE clinical trial results to the many attendees at the ASH meeting and that ASH has recognized the importance of this trial by including the ENABLE abstract in its Highlights of ASH program, which features evolving therapies. We are currently in discussions with potential partners to further advance bafetinib's clinical development as we focus our clinical efforts on our other two promising drug candidates, INNO-206 and tamibarotene.”

About ASH

The American Society of Hematology (ASH) is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology.

About Bafetinib

CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. Originated by Kyoto, Japan-based Nippon Shinyaku Co. Ltd., bafetinib is a potent, orally available, rationally designed, Bcr-Abl, Lyn and Fyn kinase inhibitor, which was being 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 Ph+ CML by the U.S. Food and Drug Administration (FDA).

About B-CLL

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 U.S. 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 have a median overall survival of one to five years.

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: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx plans to initiate an international Phase 2b clinical trial as a treatment for soft tissue sarcomas in December 2011, while completing its Phase 1b/2 clinical trial. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL). 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 clinical trials, including its clinical trial with bafetinib in patients with B-CLL or any additional clinical evaluation in combination with other anti-cancer agents, the risk that any further results from the Company’s ENABLE clinical trial might not be consistent with the announced results or determined to be as favorable as or more favorable than results seen in competing drug candidates, the risk that patients administered a higher dose of bafetinib might not respond favorably or might exhibit adverse events not seen at the lower dose, uncertainties related to CytRx’s plan to seek a partner to further the clinical development of bafetinib, uncertainties regarding regulatory approvals for current and future clinical testing and the scope of the clinical testing that may eventually be required by regulatory authorities, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx's oncology drug candidates, including bafetinib, risks related to CytRx's ability to manufacture its drug candidates 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, 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.