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Genzyme Announces Positive Initial Observations In Trial Evaluating Novel Oral Treatment For Gaucher Disease
Genzyme Corp.
(Nasdaq: GENZ) announced today that it has completed enrollment in the
ongoing Phase 2 trial of Genz-112638, a novel oral therapy being developed
for the treatment of Gaucher disease. Based on positive results seen in the
trial to date, Genzyme intends to meet with regulatory agencies in the
coming weeks to discuss an expedited development strategy.
Initial observations from the first five patients suggest that
Genz-112638 may produce a rapid and meaningful impact on important clinical
endpoints including reductions in spleen and liver volume, and an increase
in platelet counts and hemoglobin concentration. Safety observations from
all patients enrolled to date suggest that the only drug-related adverse
events seen in the trial have been mild and transient in nature, including
one possibly related serious adverse event that is currently being
investigated. These early findings will be presented today at Genzyme's
Analyst Day, and full trial results will be available in mid-2008.
If these early improvements continue and are observed in other patients
enrolled in the trial, Genz-112638 may represent a promising novel approach
to treating patients with Gaucher disease.
"We are very encouraged by our first observations from this trial,"
said David Meeker MD, president of the Lysosomal Storage Disorder business.
"Cerezyme has had a remarkable effect on the lives of patients with Gaucher
Disease. We have set a very high bar for ourselves in trying to develop a
convenient oral therapy that can provide a safe and effective choice for
patients. We look forward to developing this molecule further and exploring
the role it may play in the treatment of patients with Gaucher disease."
The open-label trial has enrolled patients with Type 1 Gaucher disease
at medical centers in Europe, Israel, North America and South America.
About Genz-112638
Genz-112638, a novel ceramide analog given orally, is designed to
inhibit the enzyme glucosylceramide synthase, which results in reduced
production of glucocerebroside. This is the substance that builds up in the
cells and tissues of people with Gaucher disease. In preclinical studies,
the molecule has shown high potency and specificity. In addition to Gaucher
disease, there are a variety of other conditions that can be caused by
malfunctions in the pathway targeted by this molecule, such as Fabry
disease, and Genzyme intends to explore studies in this area.
Initiation of the Phase 2 program followed completion of an extensive
pre- clinical research effort and a Phase 1 program that involved more than
120 subjects in three separate studies.
Genzyme's Commitment to Gaucher Disease
Development of Genz-112638 reflects Genzyme's long-standing commitment
to improving the care of patients with Gaucher disease. Since introducing
Ceredase in 1991, Genzyme has engaged in extensive basic science research
to further improve the management of Gaucher patients. Post-approval
experience has helped to demonstrate the positive and enduring impact
Ceredase and Cerezyme can have on different manifestations of the disease,
such as anemia, thrombocytopenia, hepatosplenomegaly, and bone involvement.
Data generated by the Gaucher Registry, the largest database of its kind,
have yielded insights that have shaped how physicians and their patients
manage Gaucher disease. Genzyme has also conducted extensive research into
gene therapy for single gene disorders like Gaucher disease.
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 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 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 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.
Forward Looking Statements
This press release contains forward-looking statements regarding
Genzyme's business plans and strategies, including: Genzyme's intention to
meet with regulatory authorities to discuss an expedited regulatory
strategy and the expected timing of that meeting; the potential of
Genz-112638 to treat Gaucher disease; and Genzyme's intention to pursue
studies of Genz-112638 for treatment of other diseases. These statements
are subject to risks and uncertainties that could cause actual results to
differ materially from those forecast in these forward-looking statements.
These risks and uncertainties include, among others, Genzyme's ability to
successfully complete clinical development of, and secure regulatory
approvals for, Genz-112638 for the treatment of Gaucher disease; that early
improvements in patients are not observed in new patients and/or over a
longer period of time; the willingness of regulatory authorities to meet
with Genzyme and approve an expedited regulatory strategy; and the risks
and uncertainties described in Genzyme's SEC reports filed under the
Securities Exchange Act of 1934, including the factors discussed under the
caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the
period ended March 31, 2007. 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) is a registered trademark of Genzyme Corporation. All rights
reserved.
Genzyme Corp.
http://www.genzyme.com
Genzyme anunta pozitivã iniþialã observaþiile în proces de evaluare oralã roman de tratament pentru boala Gaucher - Genzyme Announces Positive Initial Observations In Trial Evaluating Novel Oral Treatment For Gaucher Disease - articole medicale engleza - startsanatate