p53 Mutation Analysis Offers Critical Prognostic and Predictive Information
for B-Cell Chronic Lymphocytic Leukemia
CAMBRIDGE, Mass., July 27 /PRNewswire-FirstCall/ -- 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(R) (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(R) (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(R) and Campath(R) are registered trademarks of Genzyme
Corporation. Gleevec(R) is a registered trademark of Novartis
Pharmaceuticals Corporation.
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 Sally Curley
+1-205-943-8312 +1-617-768-6140
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com
CONTACT:
Laura Boscarino (media contact),
+1-205-943-8312, or Sally Curley (investor contact),
+1-617-768-6140, both of Genzyme Corporation
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