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Genzyme Launches Minimal Residual Disease Test for Common Leukemia

New Diagnostic Test Complements B-CLL Treatment Campath(R)

CAMBRIDGE, Mass., July 19 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ - News) announced today that it has launched a new test to detect very low levels of disease, also known as minimal residual disease (MRD), in patients with B-cell chronic lymphocytic leukemia (B-CLL). MRD refers to undetectable disease in the blood and bone marrow of patients in complete remission. According to a recent study published in the Journal of Clinical Oncology, the elimination of disease to this extremely low level may improve the overall survival and treatment-free survival of patients with this common form of leukemia. This is the first cancer test Genzyme has launched to complement the B-CLL treatment Campath® (alemtuzumab) and demonstrates its business strategy to provide comprehensive cancer care from diagnostics to therapeutics to follow-up monitoring.

The new four-color flow cytometry test is designed to detect the presence of residual disease in the blood and bone marrow at far more sensitive levels than the light microscope or a bone marrow biopsy, which have been traditionally used to detect leukemia. This technology can identify as few as one single CLL cell in 10,000 white blood cells. Genzyme's test was based on a protocol developed by leading investigators at Leeds Teaching Hospitals in the United Kingdom who participate in an international consortium to promote better diagnosis and treatment of CLL.

"Genzyme Genetics is at the forefront of a new era of personalized medicine that is intended to provide physicians with the critical information they need to make the best treatment decisions with their patients," said Mara Aspinall, president of Genzyme Genetics, the business unit of Genzyme Corporation focused on performing diagnostic tests in both the cancer and reproductive medicine areas. "This new test will help oncologists monitor response to therapy in their CLL patients using a highly sensitive, non- invasive technology."

According to a study published in the May 1, 2005 issue of the Journal of Clinical Oncology, 84 percent of patients who had no detectable CLL cells after receiving Campath had survived for at least 5 years. Twenty percent of these same patients had previously failed to respond or had relapsed after receiving other chemotherapy for their disease. CLL patients who relapse from or are refractory to chemotherapy have the poorest prognosis with a median survival of 10 months.

Schering AG, Germany (NYSE: SHR; FSE: SCH) holds exclusive worldwide marketing and distribution rights to Campath. The product is marketed in the U.S. by Berlex Oncology, a U.S. affiliate of the Schering AG Group, under license from Genzyme. Campath was launched in the U.S. in June 2001, and in Europe, where it is named Mabcampath(TM), in August 2001. Studies are currently underway to support the potential expansion of Campath's label for earlier-line use in B-CLL.

"The availability of this test is an important advance for CLL patients and their physicians and we believe it will make a fundamental difference in care," said Mark Enyedy, senior vice president and general manager of Genzyme Oncology. "This is a significant milestone for Genzyme as we move towards building a well-differentiated oncology franchise that incorporates patient stratification as a critical component of our therapeutic and commercial development. This is the first of many targeted diagnostic tests we hope to launch that will further integrate Genzyme's oncology diagnostics and therapeutic portfolios."

The introduction of this MRD test for leukemia is the first of a number of major new cancer diagnostic tests Genzyme Genetics plans to launch this year, all of which will be designed to help identify which patients are likely to respond to targeted cancer therapies. Genzyme expects to launch a diagnostic test for the epidermal growth factor receptor (EGFR) markers that can be used to help identify patients who are most likely to respond to targeted lung cancer therapies later this year. In May, Genzyme entered into a license agreement with the Massachusetts General Hospital (MGH) and Dana-Farber Cancer Institute (DFCI) to obtain exclusive, worldwide diagnostic rights to their discovery of the EGFR gene mutations.

About B-cell Chronic Lymphocytic Leukemia

B-CLL is the second most common leukemia, with the majority of cases occurring in patients over the age of 55. The Leukemia and Lymphoma Society estimates that there will be approximately 8,200 new cases of B-CLL in 2005. It usually progresses slowly and is characterized by the accumulation of lymphocytes, or special white blood cells, in the bone marrow. These cells can overwhelm the bone marrow and invade the blood stream, eventually spreading to the spleen, liver and other solid organs.

About Campath

Campath is the first and only humanized monoclonal antibody approved for B-CLL and is the first product with proven efficacy in B-CLL patients who have failed both alkylating agents and fludarabine phosphate treatment. Determination of the effectiveness of Campath is based on overall response rates. Comparative, randomized trials demonstrating increased survival or clinical benefits such as improvement in disease-related symptoms have not yet been conducted. Campath targets the CD52 antigen found on the surface of both cancerous and noncancerous lymphocytes, but not on the surface of cells that have the ability to mature and differentiate into new, healthy lymphocytes.

This activity is called hematopoietic cell sparing, which refers to the absence of effect on the precursors of normal blood elements such as neutrophils, erythroid cells and platelets. Once Campath binds to the CD52 antigen on a lymphocyte, it works to kill the cell through a variety of mechanisms that seek out and selectively destroy the malignant cells through natural processes. It also stimulates the body's natural defense mechanisms to destroy the malignant cell. These various mechanisms of action are likely responsible for the removal of malignant lymphocytes from the blood, spleen, and bone marrow after injection. Although Campath has some effect in removing malignant lymphocytes that have accumulated in the lymph nodes and extranodal masses, its activity is best at clearing the bone marrow of diseased cells, thus allowing the body to replenish healthy lymphocytes.

Campath is contraindicated in patients who have active systemic infections, underlying immunodeficiency (e.g., seropositive for HIV), or known Type 1 hypersensitivity or anaphylactic reactions to Campath or to any one of its components.

The most commonly reported infusion-related adverse events were rigors (86%), drug-related fever (85%), nausea (54%), vomiting (41%), and hypotension (32%). Hematologic toxicities included pancytopenia/marrow hypoplasia (6%), anemia (80%), thrombocytopenia (72%), neutropenia (85%), and profound lymphopenia, and should be monitored. Infections reported included sepsis (15%), pneumonia (16%), and opportunistic infections such as CMV (8%-study 1), Candidiasis (5%-study 1), Aspergillosis (2%-study 1), and Mucormycosis (2%- study 1).

About Genzyme Genetics

Genzyme Genetics is a leading, nationwide provider of high-quality, complex diagnostic testing 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 Genzyme Corporation

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. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with annual revenues exceeding $2 billion and more than 7,000 employees in locations spanning the globe. With many established products and services helping patients in more than 80 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 immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.

This press release contains forward-looking statements, including statements regarding the sensitivity of the diagnostic test and its ability to detect MRD in CLL patients, expectations that the test will be used by oncologists to provide the most effective therapy for CLL patients, plans to launch additional cancer diagnostic tests, and the timing thereof, and potential expansion of the Campath label. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, scientific, technical and manufacturing issues that could prevent the successful launch of the diagnostic test, the failure of the test to produce diagnostic results as anticipated, the commercial acceptance of the test, including the acceptance of a MRD in CLL test at price levels that are economically viable for Genzyme Genetics, Genzyme's ability to successfully complete development of Campath as an earlier-line treatment for B-CLL, and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Factors Affecting Future Operating Results" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.

Genzyme® and Campath® are registered trademarks and MabCampath(TM) is a trademark of Genzyme Corporation or its subsidiaries. All rights reserved.

Genzyme's press releases and other company information are available at http://www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.

Media Contact: Investor Contact:
Laura Boscarino Kristen Galfetti
(205) 943-8312 (617) 768-6563

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Source: Genzyme Corporation

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