August 25, 2008

Moffitt Cancer Center Chief Participates in Clinical Trial Resulting in FDA Approval of New Label for Myelodysplastic Therapy VIDAZA

The Moffitt Cancer Center announced today that Dr. Alan List, Physician-in-Chief, was one of the key investigators in a VIDAZA (azacitidine) clinical trial (AZA-001) whose results the U.S. Food & Drug Administration (FDA) has approved to add to the drug's label. In May 2004, VIDAZA was the first drug approved by the FDA for the treatment of MDS.

The AZA-001 study is the largest ever phase III; multi-center randomized trial involving higher-risk MDS patients. This study found that VIDAZA is the first and only agent to significantly extend survival in these patients. On average, patients who received VIDAZA lived more than nine months longer than those who received conventional care regimens (CCR) and had a nearly double two-year survival rate.

"I am excited to have been involved in the planning and analysis of the AZA-001 trial, which represents a major therapeutic milestone for patients with MDS, and is the first study ever to show that a non-transplant medical therapy can significantly extend survival for patients with higher risk forms of MDS," said List, "This study demonstrates the importance of continued research of incurable, difficult to treat conditions, such as MDS, and illustrates the clinically meaningful benefit of agents like VIDAZA can have for patients."

Patients in the trial who received VIDAZA also reduced the need for blood transfusions. In fact, nearly half (45 percent) of patients who were transfusion dependent at the start of the trial achieved transfusion independence while on VIDAZA. These were durable results and, on average, patients who received VIDAZA remained transfusion independent for 13 months.

MDS is a cancer of the bone marrow stem cells in which the bone marrow fails to make enough functioning blood cells - either red blood cells, white blood cells or platelets, and more than a third of patients progress to acute myeloid leukemia over time. It is not known exactly how many people have MDS, however, it is estimated that approximately 300,000 people are affected worldwide and about 20,000 to 25,000 new cases are diagnosed each year in the United States.

VIDAZA is the first and only epigenetic therapy, a new class of anti-cancer compounds which can change the regulation of gene expression, to have demonstrated a survival benefit in any cancer.

About H. Lee Moffitt Cancer Center & Research Institute

Located in Tampa, Florida, Moffitt Cancer Center is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer. Moffitt's sole mission is to contribute to the prevention and cure of cancer.