– Bafetinib’s statistically significant inhibition of glioblastoma multiforme cells demonstrates tremendous potential for this drug candidate –
– Initiation of Phase 2 clinical trial evaluating bafetinib in glioblastoma multiforme on track for second half of 2010 –
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, 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).
About Glioblastoma Multiforme
Glioblastoma multiforme is a rapidly growing tumor of the central nervous system. It is the most common and deadliest type of primary brain tumor. Glioblastoma multiforme is more common among males, particularly men between the ages of 40 and 60 years. The overall annual incidence of primary malignant brain tumors is six to seven per 100,000 people, of which approximately half are glioblastoma multiforme.
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, including INNO-206, bafetinib and tamibarotene. CytRx recently announced plans to initiate three Phase 2 clinical trials with its oncology candidate INNO-206 as a treatment for pancreatic cancer, gastric cancer and soft tissue sarcomas. The Company also has announced plans to initiate three Phase 2 clinical trials with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL), glioblastoma multiforme (a common and aggressive type of primary brain tumor) and advanced prostate cancer. In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 28% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit www.cytrx.com.
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 ability to obtain regulatory approval for clinical testing of bafetinib, including the planned Phase 2 clinical trial for patients with glioblastoma multiforme, the scope of clinical testing that may be required by regulatory authorities and the timing and outcome of further clinical trials, the risk that any future human testing of bafetinib for glioblastoma multiforme might not produce results similar to those seen in preclinical studies, 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 and, risks related to the future market value of CytRx's investment in RXi and the liquidity of that investment, 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.
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