CytRx commences PROACT Phase 2 clinical trial of bafetinib for advanced prostate cancer

CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer.

“We are truly delighted to be working with City of Hope, an institution that is recognized by the National Cancer Institute for its excellence in cancer research, treatment and education”

The open-label PROACT trial is being conducted at City of Hope, located just outside of Los Angeles, California, as well as multiple clinical sites in India. In the trial, approximately 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with chemotherapy will receive orally available bafetinib twice daily. The trial endpoints are reduction in prostate-specific antibodies and increases in progression-free survival compared to baseline and historical data.

"We are truly delighted to be working with City of Hope, an institution that is recognized by the National Cancer Institute for its excellence in cancer research, treatment and education," said Steven A. Kriegsman, CytRx President and CEO. "The treatment of hormone-refractory prostate cancer has been unsatisfactory with currently approved treatments involving substantial toxicity and extending survival by only a few months. An agent that could prevent growth of advanced-stage prostate cancer with reduced side effects could provide a significant quality-of-life improvement and represent a giant step forward in the treatment of this disease. Bafetinib has the potential to be such a drug."

CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D., stated, "Bafetinib is a dual protein kinase inhibitor targeting both Bcr/Abl and Lyn kinases. Hormone-refractory prostate tumor specimens overexpress Lyn kinase compared to prostatic tumor samples from the same individuals taken before hormone-deprivation therapy. This suggests that Lyn kinase may be required for tumor cell growth and progression. Thus the administration of bafetinib, which inhibits Lyn kinase, may stop the growth of hormone-refractive prostate cancer."

CytRx is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer and plans to begin a Phase 1 trial in brain cancer shortly.

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. The National Cancer Institute estimates that more than 217,000 new cases and more than 32,000 deaths will be attributed to prostate cancer in the U.S. this year. 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.

SOURCE CytRx Corporation