CAMBRIDGE, Mass.--Genzyme Corporation announced today that it has begun treating patients in a phase 2 clinical trial examining the safety and effectiveness of Clolar® (clofarabine) 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 clofarabine 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.
"While the outlook for children and young adults with AML has improved during the last three decades due to advances in chemotherapy and bone marrow transplant, the majority of AML patients are over the age of sixty years and not able to tolerate these curative approaches," stated Harry Erba, M.D., Ph.D., of the University of Michigan Comprehensive Cancer Center. "This Genzyme-sponsored trial of clofarabine represents an attempt to develop a new effective therapy for this aggressive leukemia that can be tolerated by older patients."
Hagop M. Kantarjian, M.D. of The University of Texas M. D. Anderson Cancer Center, added that complete remission and response rates remain low among older AML patients. "Standard therapies for AML in this population are unsatisfactory. Older patients are often faced with treatment choices at either end of the spectrum: either toxic combination chemotherapy that has a high chance of treatment-related morbidity and mortality despite a low chance of cure, or very shortened survival with supportive care alone."
The clinical trial, known as CLASSIC II, builds on promising results from two phase 2 studies of clofarabine in previously untreated older patients with AML deemed unfit for chemotherapy. These studies were conducted by Alan Burnett, M.D., of Cardiff University in the United Kingdom. Dr. Burnett will present updated results from his UK clinical trials at the annual American Society of Hematology meeting taking place next month in Orlando, Florida.
How does clofarabine work?
Clofarabine is a purine nucleoside antimetabolite; which means it mimics one of the sugars in the DNA backbone. It is converted to it's toxic form once inside the body and inhibits DNA synthesis, such that cancer cells cannot replicate and grow. Side effects include tumor lysis syndrome which is the body's reaction to dead cells in the blood.
Genzyme Biotechnology (Nasdaq:GENZ) is trading down this morning 94 cents or 1.4% at 64.23.
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