CytRx to Conduct Phase 2 Clinical Trial with Bafetinib in B-cell Chronic Lymphocytic Leukemia
LOS ANGELES, Jan 13, 2010 (BUSINESS WIRE) -- CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced plans to initiate a Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib (formerly known as INNO-406) in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL).
CytRx President and CEO Steven A. Kriegsman, stated, "We believe bafetinib is a cutting-edge treatment that could be efficacious in a wide range of hematological cancers. Our objective is to evaluate results from this trial, and if successful, quickly progress into later-stage clinical trials either internally or with partners. An effective treatment could result in a multi-billion dollar oncology product for CytRx."
In the planned Phase 2 trial, approximately 20 patients who have failed treatment with first-line agents will be administered daily oral doses of bafetinib. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Based on trial results, CytRx plans to conduct a larger comparative trial to further determine efficacy of this agent.
Leukemias are cancers of the white blood cells. B-CLL involves an abnormal and malignant proliferation of a particular subtype of white blood cells known as a B cell. B cells originate in the bone marrow, develop in the lymph nodes and normally fight infection. In B-CLL, the DNA of a B cell is damaged, making it unable to fight infection. Additionally, these damaged B cells proliferate and accumulate in the bone marrow and blood, where they crowd out healthy blood cells.
"We are optimistic that our dual protein kinase inhibitor bafetinib will demonstrate efficacy in patients with high-risk B-CLL who have failed other therapies and have few viable treatment options," said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. "Bafetinib has shown significant activity in blocking B-CLL cell proliferation in vitro and caused increased cancer cell death. Additionally, bafetinib has demonstrated anti-tumor activity in patients with chronic myelogenous leukemia, who have failed first- and second-line therapy with other kinase inhibitors."
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 United States 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.
Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, which is currently being planned as a third-line treatment for patients with chronic myeloid leukemia (CML) or 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 Phase I 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 dasatiniband nilotinib). INNO-406 has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the FDA.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a clinical trial for the treatment of acute promyelocytic leukemia (APL). CytRx recently announced plans to initiate Phase 2 trials with its oncology candidate INNO-206 as a treatment for gastric cancer, soft tissue sarcomas and pancreatic 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 36% 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 B-CLL, 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 B-CLL might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture its drug candidates, including bafetinib, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's ability to enter into partnerships or other transactions to advance the clinical development of its portfolio of drug candidates, 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, 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.
SOURCE: CytRx Corporation
Legend Securities, Inc.Thomas Wagner800-385-5790 x152718-233-2600 [email protected]