August 16, 2006

TAMPA, Fla.  – The Food and Drug Administration recently approved Dacogen™ by injection in patients with myelodysplastic syndromes (MDS). Dr. Hussain Saba, senior member of the Malignant Hematology Program at H. Lee Moffitt Cancer Center & Research Institute was the principal investigator for this clinical trial. The trial was also conducted at the James A. Haley Veterans Hospital as well as 21 treatment centers across the country.

“Treatment for patients with MDS has not been successful,” says Saba. “However, significant advances have recently been made in the treatment of this disease. Besides growth factors like Procrit for anemia and Neupogen for low white cell count, there are only three drugs approved for treatment of MDS: Vidaza™, Revlimid™ and Dacogen™.”

Moffitt can be credited with leading the investigation of Revlimid™ and Dacogen™ for their effectiveness as treatment and their recent approval by the FDA.

In this trial, 89 MDS patients were randomized to Dacogen™ therapy plus supportive care, while 81 were randomized to receive supportive care alone. Supportive care consisted of blood product transfusions and antibiotics.

A total of 21 percent in Dacogen™-treated patients who received atleast two cycles of treatment, compared to none in the supportive care arm. All patients who responded to treatment became or remained transfusion independent during the time of the response. It was recommended that patients be treated with Dacogen™ for a minimum of four cycles


and treatment can continue as long as the patient continues to benefit.

In 2001, H. Lee Moffitt Cancer Center & Research Institute earned NCI Comprehensive

Cancer Center status in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. 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 America’s Best Hospitals for cancer. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.