CytRx's ENABLE Phase 2 Trial Results with Bafetinib in Relapsed B-Cell Chronic Lymphocytic Leukemia to be Presented at the Prestigious 53rd Annual ASH Meeting
– Presentation to be given by Dr. Tapan Kadia of M.D. Anderson Cancer Center –
LOS ANGELES--(BUSINESS WIRE)--Oct 4, 2011 - CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that an abstract with results from the Company's ENABLE Phase 2 proof-of-concept clinical trial with its Bcr-Abl, Lyn and Fyn kinase inhibitor bafetinib for the treatment of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments will be presented in a poster session at the 2011 American Society of Hematology (ASH®) Annual Meeting on Sunday, December 11, 2011 at 6:00 p.m. Pacific time at the San Diego Convention Center, Hall GH. The abstract, “A Pilot Phase II Study of the Lyn Kinase Inhibitor Bafetinib in Patients with Relapsed or Refractory B Cell Chronic Lymphocytic Leukemia,” also will be published in print and online in the November 18, 2011, supplemental volume of the peer-reviewed ASH journal Blood. The abstract was authored by Tapan Kadia, M.D., Maria Delioukina, M.D., Hagop Kantarjan, 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.
“We are delighted that the ASH committee accepted the ENABLE trial abstract for presentation at this prestigious medical conference,” said CytRx President and CEO Steven A. Kriegsman. “Earlier this year we reported favorable preliminary results from the ENABLE trial, and believe that our drug candidate's unique kinase inhibitor formulation could be efficacious in treating B-CLL and other cancers where approved therapies have failed.”
In June 2011, CytRx announced that preliminary results from its ENABLE Phase 2 trial demonstrated that bafetinib was clinically active in a group of patients with B-CLL who have failed several other treatments for their cancer. “Completion of the ENABLE clinical trial marks an important early milestone in our business strategy to advance development of our oncology pipeline using proof-of-concept trials in patients with advanced-stage cancers. This strategy allows us to assess preliminary efficacy and safety results cost-effectively and quickly following trial initiation before potentially moving into larger clinical trials,” added Mr. Kriegsman. “At this point, we are now actively seeking a partner to further advance bafetinib's clinical development.”
The ENABLE Phase 2 trial currently includes a total of 18 patients and is being performed at M.D. Anderson Cancer Center and City of Hope Medical Center. Patients self-administer bafetinib twice daily every day and continue treatment as long as their cancer is controlled and no intolerable side effects occur.
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 in the high-risk B-CLL have a median overall survival of one to five years.
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.
CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. 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(R) 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 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 a Phase 2b clinical trial as a treatment for soft tissue sarcomas in 2011, following its Phase 1b dose escalation safety trial. 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. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL).
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, the risk that future results from the Company's ENABLE clinical trial might not be consistent with the announced preliminary results, 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 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.
Posted: October 2011