Healthcare Industry News: Berlex Laboratories
News Release - July 27, 2006
Genzyme Launches New Diagnostic Test for Common Blood Cancerp53 Mutation Analysis Offers Critical Prognostic and Predictive Information for B-Cell Chronic Lymphocytic Leukemia
CAMBRIDGE, Mass., July 27 (HSMN NewsFeed) -- Genzyme Corporation (Nasdaq: GENZ ) announced today the availability of its p53 Mutation Analysis for B-cell chronic lymphocytic leukemia (B-CLL). P53 is a tumor suppressor gene that stops cell division when DNA damage is present. When the p53 gene does not function normally, genetic mutations that can occur in dividing cells remain unchecked, thereby leading to the accumulation of abnormal, malignant cells. Mutations in p53 are present in greater than 50 percent of all human cancers, including colon, breast, lung, bladder, brain, liver, and hematological malignancies.
"It is well known that p53 mutations and deletions are associated with poor survival in B-CLL patients," said hematologist/oncologist Mark Goldberg, M.D., senior vice president, clinical research. "Genzyme's p53 Mutation Analysis will provide oncologists and their patients with additional important prognostic and predictive information and help them determine the best treatment options."
A significant number of patients with B-CLL have a dysfunctional p53 gene caused by mutations and deletions, and this number increases as the disease progresses. Studies show that p53 is a poor prognostic factor in B-CLL.
Currently, physicians generally test for p53 deletions using a technology known as "fluorescent in-situ hybridization" (FISH). FISH detects a deletion of a fragment of chromosome 17 that bears the p53 gene. However, B-CLL patients may have a p53 deletion, mutation, or both. Genzyme's new test is a gene sequencing assay that detects specific mutations in the p53 gene with a higher degree of sensitivity than FISH alone, thereby providing more comprehensive diagnostic information for high-risk patients. With the new availability of the p53 Mutation Analysis, Genzyme is expanding its diagnostic menu for B-CLL patients. The company also offers a minimal residual disease test, which detects very low levels of disease in B-CLL patients.
Genzyme believes that effective cancer treatment requires personalized medicine, directing specific therapies at the patients most likely to benefit from them. This important convergence of diagnostics and therapeutics is a priority for Genzyme.
In 2005, Genzyme launched three new cancer tests directly related to understanding a patient's response to targeted therapies. This year, Genzyme introduced an important new test to monitor drug resistance in chronic myeloid leukemia patients who are treated with Gleevec® (imatinib mesylate) and launched two new molecular tests for acute myelogenous leukemia (AML): FLT3 Mutation Analysis and WT1 RQ-PCR. FLT3 mutations are considered a prognostic indicator of poor survival and response to standard chemotherapies. The WT1 RQ PCR test allows physicians to monitor AML patients for early relapse during and following therapy. Together, these tests may enable oncologists to better manage their patients.
"The availability of these new tests are just the beginning of Genzyme's commitment to deliver life-saving targeted medicine," said Mara Aspinall, president of Genzyme Genetics, the business unit of Genzyme Corp. focused on the research, development and provision of complex testing services. "We will continue to develop innovative testing that helps physicians select appropriate therapies for their patients."
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.
Campath® (alemtuzumab) is indicated in the United States for the treatment of patients with B-CLL who have been treated with alkylating agents and have failed fludarabine therapy. Genzyme and Schering AG, Germany, are co-developing Campath in oncology and other indications. The product is marketed in the United States by Berlex Laboratories, a U.S. affiliate of Schering.
Campath is the first and only humanized monoclonal antibody approved for the treatment of B-CLL in patients who have failed both alkylating agents and fludarabine phosphate treatment. Campath works by targeting the "CD52" antigen, which is one of the most common antigens found on B and T cells. When Campath binds to this CD52 antigen, it activates the immune system to destroy targeted cells not only in the blood but also in the bone marrow. Campath is not currently indicated as a first-line treatment in CLL.
Campath should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Campath has a boxed warning which includes events of hematologic toxicity, infusion reactions, and infections/opportunistic infections.
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, drug-related fever, nausea, vomiting, and hypotension. Hematologic toxicities included pancytopenia/marrow hypoplasia, anemia, thrombocytopenia, neutropenia, and profound lymphopenia, and should be monitored. Infections reported included sepsis, pneumonia, and opportunistic infections such as CMV, candidiasis, aspergillosis, and mucormycosis.
About Genzyme Genetics
Genzyme Genetics is a leading, nationwide provider of high-quality, complex testing services for physicians and their patients. With CLIA-certified laboratories and counseling facilities located across the U.S., Genzyme Genetics offers extensive diagnostic 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. This year marks the 25th anniversary of Genzyme's founding. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 8,500 employees in locations spanning the globe and 2005 revenues of $2.7 billion. Genzyme has been 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 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 the statements regarding the ability of p53 Mutation Analysis to provide important prognostic and predictive information and to help physicians select appropriate therapies, and Genzyme Genetics' future development of innovative testing. 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, the failure of p53 Mutation Analysis to produce diagnostic results as anticipated, the inability for physicians to personalize therapy as expected notwithstanding physicians' access to p53 Mutation Analysis, the continued availability of p53 Mutation Analysis resulting from the lack of commercial acceptance of p53 Mutation Analysis, including the acceptance of the tests at price levels that are economically viable for Genzyme Genetics, the existence of scientific and technical issues that prevent the development of further innovative tests, 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 ending March 31, 2006. 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 of Genzyme Corporation. Gleevec® is a registered trademark of Novartis Pharmaceuticals Corporation.
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