Cytrx to commence Phase 2 trial of bafetinib for advanced prostate cancer

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.