CytRx Corp. (CYTR) Announces Positive Data for Drug Candidate Bafetinib

May 27, 2010 8:35 AM EDT
CytRx Corporation (NASDAQ: CYTR) today announced that its drug candidate bafetinib (formerly known as INNO-406) demonstrated statistically significant inhibition of glioblastoma multiforme cell lines in a preclinical trial. Glioblastoma multiforme is the most common and aggressive primary adult brain tumor. Data from the trial, titled “Preclinical evaluation of Lyn kinase inhibition for treatment of glioblastoma multiforme,” will be presented in a poster at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8, 2010 in Chicago. It was authored by Vamsidhar Velcheti, M.D.; Brittany Peterson; Daniel Levitt, M.D., Ph.D.; and Om Prakash, Ph.D. Dr. Levitt is CytRx’s Chief Medical Officer and the bafetinib used in the trial was supplied by CytRx. CytRx also said that it is on track with previously announced plans to initiate a Phase 2 proof-of-concept clinical trial evaluating the efficacy and safety of the potent, orally available, dual kinase inhibitor bafetinib in patients with glioblastoma multiforme in the second half of 2010.

“We are delighted that a trial featuring bafetinib will be presented at this year’s Annual Meeting of ASCO, the world’s leading professional organization representing physicians who care for patients with cancer. Organizers expect this year’s meeting will draw more than 30,000 cancer specialists from around the world,” said CytRx President and CEO Steven A. Kriegsman. “The acceptance of this trial for presentation strengthens our confidence to move forward with additional clinical development of bafetinib in glioblastoma multiforme. We believe that bafetinib could be efficacious in several hematological cancers and we also are preparing to begin evaluating bafetinib in a Phase 2 proof-of-concept clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) this quarter, as well as a Phase 2 clinical trial in advanced prostate cancer next quarter.”

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).

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