Genzyme Begins Phase II Leukemia Trial

Genzyme Corp. has begun treating patients in a Phase II trial examining the safety and effectiveness of Clolar in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy. This is Genzyme’s second pivotal clinical study of Clolar in adult patients with AML to commence this year, and it is expected to provide substantial support for expanding the current product label.

“We are very pleased to begin treatment in this clinical study as we seek to expand Clolar therapy to adult patients,” stated Mark Enyedy, senior vice president and general manager of Genzyme Oncology. “Significant data from investigator-sponsored clinical trials have already been presented regarding the use of Clolar in adult AML and show very encouraging results. The start of this new clinical study is another important step in our plan to broaden Clolar’s label to benefit a larger patient population and address multiple lines of adult AML.”

The trial is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. According to the American Cancer Society, each year approximately 6,500 people over the age of 60 are diagnosed with AML in the U.S. The median survival for those receiving therapy can vary from one to thirteen months, and the five-year survival rate over the past three decades remains at less than 15 percent. Standard therapy is poorly tolerated and early induction mortality exceeds 30 percent in patients with poor risk factors.