CytRx to Initiate a Phase 2 Clinical Trial with Bafetinib in Advanced Prostate Cancer

LOS ANGELES--(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 in the second half of 2010 to evaluate the effectiveness and safety of its oncology drug candidate bafetinib (formerly known as INNO-406) in patients with an advanced form of prostate cancer known as metastatic hormone-refractory prostate cancer.

“Although chemotherapy increases the survival time of advanced-stage prostate cancer patients, these agents are quite toxic. Potent, orally available bafetinib could improve survival and provide these patients with a better quality of life by reducing drug-related side effects”

CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D., stated, “We see an opportunity for bafetinib in the treatment of this advanced-stage cancer due to its ability to inhibit Lyn kinase. Lyn kinase is over-expressed in hormone-refractory prostate tumor specimens compared to tumor samples from the same individuals taken before hormone therapy. The inhibition of Lyn kinase has been shown to prevent prostate tumor growth and lymph node metastases in mouse models. By inhibiting Lyn kinase, bafetinib could have a role in the treatment of these advanced-stage cancer patients by blocking the growth and progression of metastatic hormone-refractory prostate tumors.”

“Although chemotherapy increases the survival time of advanced-stage prostate cancer patients, these agents are quite toxic. Potent, orally available bafetinib could improve survival and provide these patients with a better quality of life by reducing drug-related side effects,” said CytRx President and CEO Steven A. Kriegsman. “We plan in the second half of 2010 to commence this Phase 2 clinical trial, which will be in addition to two previously announced Phase 2 clinical trials with bafetinib in patients with advanced-stage cancers. These multiple, cost-efficient trials are geared to provide us with indications of efficacy in relatively short timeframes, fitting our strategy to aggressively advance clinical development of our oncology pipeline that includes several drug candidates with multi-billion dollar potentials.”

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 in this planned Phase 2 proof-of-concept clinical trial. 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.

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.

About Bafetinib

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 dasatinib and nilotinib. Bafetinib has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the FDA.

About CytRx

CytRx Corporation is a biopharmaceutical research and development 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 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 two Phase 2 clinical trials with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL) and glioblastoma multiforme, a common and aggressive type of primary brain tumor. 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.

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 relating to the ability to obtain regulatory approval for clinical testing of bafetinib, including the planned Phase 2 clinical trial for patients with advanced prostate cancer, 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 advanced prostate cancer 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.