National Cancer Institute Study To Determine The Optimal Time For CLL Patients To Begin Treatment

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 05 Dec 2007 - 0:00 PDT

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Genzyme Genetics, a business unit of Genzyme Corporation (Nasdaq: GENZ), announced its participation in a Cancer and Leukemia Group B (CALGB) study sponsored by the National Cancer Institute. The multi-center study will include 1,700 newly diagnosed patients with chronic lymphocytic leukemia (CLL) and is designed to test the hypothesis that early treatment of patients with certain negative risk factors leads to longer survival. Genzyme will perform the IgVH mutation analysis for the study.

"This study is critical in helping us to understand the natural history of CLL with respect to early versus delayed progression," said John Byrd, director of hematologic malignancies & co-director, Division of Hematology- Oncology, Department of Medicine, Ohio State University and a primary investigator in the study. "We chose Genzyme to perform the IgVH analysis because of its expertise in molecular testing."

IgVH is an independent prognostic marker which can be utilized to segregate patients within all stages of CLL. Studies show that CLL patients with mutations in their IgVH gene have a longer median survival (293 months) than CLL patients without these mutations (117 months). Approximately 50 to 70 percent of patients with CLL have evidence of these mutations. The National Comprehensive Cancer Network (NCCN) recommends IgVH Mutation Analysis for patients diagnosed with CLL. The assay can be performed on either peripheral blood or bone marrow aspirate. Genzyme launched its IgVH mutation analysis test in February, 2007.

"CLL is typically a slowly progressing cancer but up to 30 percent of patients with CLL progress rapidly," said Mara Aspinall, president of Genzyme Genetics. "By proactively testing for the IgVH mutation soon after initial diagnosis, doctors can identify high-risk patients and consider starting treatment earlier, possibly resulting in patients living longer."

Richard L. Schilsky, M.D., professor of medicine at the University of Chicago and chairman of the CALGB commented, "CALGB is pleased to partner with Genzyme in this important and novel study that will help to individualize the treatment of CLL."

Genzyme's participation in this study reinforces the company's commitment to furthering the role of diagnostics in the area of personalized medicine. Genzyme has been addressing the need for personalized treatment by developing tests to help physicians select appropriate therapies for their patients. Today Genzyme offers 18 innovative tests to help physicians guide treatment and save critical time for their patients with cancer.

The CALGB study will be open to its affiliate centers in the United States as well as Eastern Cooperative Oncology Group and Southwest Oncology Group sites.

About Chronic Lymphocytic Leukemia

CLL is the most prevalent form of adult leukemia, affecting approximately 120,000 people in Europe and the United States. The disease is most commonly diagnosed among people age 50 or older. CLL is characterized by the accumulation of functionally immature white blood cells (lymphocytes) in the bone marrow, blood, lymph tissue, and other organs. Two types of lymphocytes are present in the blood, B cells and T cells. About 95 percent of CLL cases involve cancerous B cells. Because these B cells have a longer than normal life span, they begin to build up and "crowd out" the normal, healthy blood cells. The accumulation of functionally immature cells in the bone marrow excludes the generation of healthy cells and can become fatal. Symptoms include fatigue, bone pain, night sweats, fevers, and decreased appetite and weight loss. Bone marrow involvement also leads to weakening of the immune system, exposing the patient to a higher risk of infection.

About Genzyme Genetics

Genzyme Genetics is a leading, nationwide provider of high quality genetic testing and genetic counseling services for physicians and their patients. With laboratories and counseling facilities located across the U.S., Genzyme Genetics offers extensive reproductive and cancer testing services, supported by innovative technology and a commitment to quality service and trusted information. Genzyme Genetics is a business unit of Genzyme Corporation.

About the Cancer and Leukemia Group B

The Cancer and Leukemia Group B (CALGB) is a national cooperative group of 29 of the country's most prestigious medical centers, and more than 250 affiliated institutions and 3,000 oncology specialists, working together on large-scale cancer clinical trials. Sponsored by the National Cancer Institute (NCI), the CALGB is headquartered with its Central Office at the University of Chicago in Chicago, Illinois, and its Statistical Center at Duke University in Durham, North Carolina.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

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