Genzyme
Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany today
announced that the first patient has been treated in the first of two
planned Phase 3 trials examining the safety and efficacy of alemtuzumab
for the treatment of multiple sclerosis (MS).
The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif®
(interferon beta-1a) in patients with relapsing-remitting multiple
sclerosis (MS). Alemtuzumab will be given in two annual cycles; Rebif
will be administered three times per week. The CARE-MS I study will
include patients who have been diagnosed with relapsing-remitting MS
but who have not yet begun treatment with any MS drug. CARE-MS II is
scheduled to begin soon and will enroll patients who have continued to
experience relapse episodes while on currently available
disease-modifying therapies.
Initiation
of this Phase 3 program follows the successful completion of the
initial treatment period in the Phase 2 trial. Interim results from the
Phase 2 trial indicated that alemtuzumab-treated patients experienced a
statistically significant reduction compared with Rebif-treated
patients in the risk for sustained accumulation of disability and the
risk for relapse for 24 months. Results of the primary outcomes from
this trial at 36 months are expected to be presented on Oct. 14 by
Professor Alastair Compston during the Charcot Award lecture at the
annual meeting of the European Committee for Treatment and Research in
Multiple Sclerosis, in Prague.
The
CARE-MS I study will enroll up to 525 patients at approximately 60
medical centers throughout North America, Australia, Latin America, and
Europe, and will again compare alemtuzumab-treated patients to
Rebif-treated patients according to two co-primary endpoints: the time
to sustained accumulation of disability, and the annualized relapse
rate. Alemtuzumab will be dosed at 12 mg/day for five days by daily IV
infusion, with a second dosing 12 months later of 12 mg/day for three
days. All patients will be followed from their entry into the trial
until two years from the date that the last patient is randomized to
treatment. Alemtuzumab-treated patients will continue to have safety
evaluations for at least three years after the last course of
treatment. The companies anticipate filing for marketing approval of
alemtuzumab for the treatment of MS in 2011.
Alemtuzumab
is an investigational drug for the treatment of MS and must not be used
outside of a formal clinical trial setting in MS patients. Physicians
or patients seeking additional information about the CARE-MS I trial
should contact Genzyme Medical Information at 1-800-745-4447, option 2
in the United States, + 31 35 6991499 in Europe, or visit www.clinicaltrials.gov.
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.
About Bayer Schering Pharma
The
Bayer Group is a global enterprise with core competencies in the fields
of health care, nutrition and high-tech materials. Bayer HealthCare, a
subsidiary of Bayer AG, is one of the world’s leading, innovative
companies in the healthcare and medical products industry and is based
in Leverkusen, Germany. The company combines the global activities of
the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals
divisions. The pharmaceuticals business operates under the name Bayer
Schering Pharma AG. Bayer HealthCare’s aim is to discover and
manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer
Schering Pharma is a worldwide leading specialty pharmaceutical
company. Its research and business activities are focused on the
following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology,
Primary Care, Specialized Therapeutics and Women's Healthcare. With
innovative products, Bayer Schering Pharma aims for leading positions
in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to
improve the quality of life. Find more information at www.bayerscheringpharma.de.