CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, announces progress with its clinical program to evaluate the preliminary efficacy and safety of its drug candidate bafetinib in three oncology indications. The Company has enrolled its first patient in a Phase 2 proof-of-concept trial in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL), is reporting rapid advancement toward the initiation of a Phase 2 proof-of-concept trial in advanced prostate cancer, and is on track to begin clinical evaluation later this year in glioblastoma multiforme, a common and aggressive type of primary brain tumor. “These are very exciting times at CytRx as we make substantial progress in advancing the clinical development of bafetinib in a variety of oncology indications,” said Steven A. Kriegsman, CytRx President and CEO. “Patient enrollment is underway in the B-CLL trial, which we are now calling ENABLE, for Effectiveness i N Advanced B-Cell Lymphocytic Leukemia. Our oncology drug development team also is focused on gaining approvals for additional clinical sites for this trial as well as for our planned advanced prostate cancer trial to increase the enrollment rate and potentially shorten the time required for trial completion. We plan to keep investors apprised of our progress with the bafetinib clinical program, as well as our clinical programs with oncology drug candidates INNO-206 and tamibarotene, as we work toward our ultimate goal of building CytRx into a world-class oncology company.” In the ENABLE Phase 2 proof-of-concept clinical trial with bafetinib in patients with B-CLL, the first patient has been enrolled at MD Anderson Cancer Center in Houston. CytRx is working toward opening additional clinical sites for the ENABLE trial, including a second prestigious site in the U.S. and several sites in India. Activities are underway to gain approval from the Indian regulatory agency (DCGI) and respective site ethics committees.
CytRx is preparing to initiate its Phase 2 trial with bafetinib in patients with metastatic hormone-refractory prostate cancer, which is now called the PROACT trial for PROstate Advanced Cancer Treatment. The PROACT trial is expected to be initiated in a prominent clinical site in the U.S., as well as multiple clinical sites in India. The investigational new drug (IND) application for bafetinib and the PROACT clinical trial protocol have been submitted to the DCGI and the proposed clinical sites are working with their respective ethics committees to obtain site approvals.“We are pleased with our progress with the bafetinib clinical program, which will allow us to further evaluate its potential in the treatment of advanced-stage cancers,” said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. “Our optimism for this drug candidate is based on a key design differentiator – its pairing of Bcr-Abl inhibitor with a potent inhibitor of Lyn kinase, which is over expressed in many cancers. Potent, orally available bafetinib could improve survival and provide these patients with a better quality of life through its ability to reduce drug-related side effects compared with many approved oncology agents that are often quite toxic.” About B-cell chronic lymphocytic leukemia (B-CLL) Leukemias are cancers of the while blood cells. B-CLL involves an abnormal and malignant proliferation of a particular subtype of white blood cells known as B cells, which originate in the bone marrow, migrate to the lymph nodes and spleen, and normally fight infection by producing antibodies. In B-CLL, the DNA of a B cell is damaged, causing a single damaged B cell to proliferate and accumulate in the bone marrow and blood, crowding out healthy blood cells. 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 with high-risk B-CLL who have failed other therapies have a median overall survival of one to five years.
In the Phase 2 proof-of-concept ENABLE clinical trial, high-risk B-CLL patients who have failed treatment with first-line agents will self-administer oral doses of bafetinib twice daily. The bafetinib dose used in this trial is based on the highest tolerated dose in a Phase 1 study led by the University of Texas MD Anderson Cancer Center in Houston. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Enrollment is expected to be completed in 12 to 14 months, with potential interim data announcements periodically.About Prostate Cancer Prostate cancer is the second most common malignancy and second-leading cause of cancer death among American men, according to the American Cancer Society. Of those diagnosed, one in 35 men will die of prostate cancer. Treatment of the disease can vary significantly from watchful waiting to surgery, radiation or both, followed by hormonal treatment. Hormonal treatment can shrink the cancer, delay its growth and reduce symptoms; however, patients with metastatic prostate cancer usually stop responding to this therapy within two years. The disease at this stage, called metastatic hormone-refractory prostate cancer, is typically treated with chemotherapeutic agents, and patients have a median survival period of less than two years, according to the National Cancer Institute. In the PROACT Phase 2 clinical trial with bafetinib, CytRx expects to enroll up to 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with either the chemotherapy agent docetaxel or mitoxantrone. The trial endpoints will be reduction in prostate-specific antibodies and increase in progression-free survival compared to baseline and historical data. The study will be conducted in several cancer treatment centers worldwide. About Bafetinib 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(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 Philadelphia chromosome-positive (Ph+) CML by the U.S. Food and Drug Administration (FDA).
About CytRxCytRx 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, bafetinib and tamibarotene. In May 2010, the Company announced initiation of a Phase 2 clinical trial with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL). CytRx also plans to initiate Phase 2 clinical trials in glioblastoma multiforme (a common and aggressive type of primary brain tumor) and advanced prostate cancer. CytRx has 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. 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 17% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). 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 Phase 2 clinical trial for bafetinib, including for B-CLL, prostate cancer and glioblastoma multiforme, uncertainties regarding regulatory approvals for current and future clinical testing of bafetinib and the scope of the clinical testing that may eventually be required by regulatory authorities for bafetinib, the significant time and expense that will be incurred in developing any of the potential commercial applications for bafetinib, including for B-CLL prostate cancer and glioblastoma multiforme, the risk that any future human testing of bafetinib for B-CLL, prostate cancer and glioblastoma multiforme 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 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.