CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a subsidiary of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY),
announced today that it will present new data from its completed Phase 2
trial of the investigational drug alemtuzumab for multiple sclerosis
(MS) at the American Academy of Neurology's (AAN) 63rd Annual Meeting in
Hawaii, April 9 - 16, 2011. Included among the additional Phase 2 trial
safety and efficacy data at AAN will be presentations on the
clinically-active disease status of patients through five-years of
patient follow-up as well as data describing a measure of vision
improvement.
“We are excited to present new alemtuzumab data at AAN that further
reflects alemtuzumab's potential as an MS treatment”
“We are excited to present new alemtuzumab data at AAN that further
reflects alemtuzumab's potential as an MS treatment,” said Michael
Panzara, Genzyme Group Vice President and Therapeutic Area Head for
Multiple Sclerosis and Immune Diseases. "We look forward to the
availability of Phase 3 results in the middle of this year.”
Alemtuzumab is a humanized monoclonal antibody being studied as a
potential therapy for relapsing-remitting multiple sclerosis (RRMS).
Genzyme is currently conducting two pivotal Phase 3 trials to evaluate
alemtuzumab in the treatment of MS. CARE-MS I is a randomized trial
comparing alemtuzumab to the approved MS therapy Rebif® (high dose
interferon beta-1a) in early, active RRMS patients who have received no
prior therapy. CARE-MS II, which also compares alemtuzumab to Rebif, is
studying RRMS patients who relapsed while on other MS therapies. Data
from these trials are expected to be available beginning in mid-2011.
Genzyme’s CAMMS223 Phase 2 trial, first reported in the New England
Journal of Medicine in 2008, compared alemtuzumab to Rebif in early,
active, RRMS patients who had received no prior therapy. In the trial,
which was larger and longer than most Phase 2 MS clinical trials,
alemtuzumab was given to patients in two or three annual cycles of not
more than five days per cycle, while Rebif was given to patients three
times per week, every week for three years. The study included an
extended phase for collection of long-term efficacy and safety data.
Alemtuzumab data to be presented at AAN:
Abstract titles
-
More Alemtuzumab Relapsing−Remitting Multiple Sclerosis Patients Are
Free of Clinical Disease Activity at Five Years (Poster PD6.003, April
14)
-
Alemtuzumab Improves Contrast Sensitivity in Relapsing−Remitting
Multiple Sclerosis Patients (Presentation S31.001, April 13)
-
Alemtuzumab Positively Affects Disability Outcomes Using a
One−Year−Sustained Criterion for Relapsing−Remitting Multiple
Sclerosis Patients in CAMMS223 (Poster P01.216, April 11)
-
Effect of Alemtuzumab vs. Interferon beta−1a on Brain Atrophy in
Patients with Early, Active Relapsing−Remitting Multiple Sclerosis
(Poster P05.042, April 13)
-
Analysis of Innate Immune Cells Following Alemtuzumab Treatment in
Human CD52 Transgenic Mice (Poster P02.201, April 12)
-
Alemtuzumab and Thyroid Autoimmunity in Relapsing−Remitting Multiple
Sclerosis Patients in CAMMS223 (Poster P03.242, April 12)
About Alemtuzumab
Alemtuzumab is a humanized monoclonal antibody being studied as a
potential therapy for relapsing-remitting multiple sclerosis.
Alemtuzumab targets the cell-surface glycoprotein CD52, which is often
expressed on T- and B-lymphocytes. Preliminary research suggests that
alemtuzumab depletes the T- and B-cells that may be responsible for the
cellular damage in MS, while potentially sparing other cells of the
immune system. Early alemtuzumab research has also suggested a
distinctive pattern of lymphocyte reconstitution in patients following
treatment.
About CAMMS223 Phase 2 Study
In the Phase 2 trial, 334 patients with early active relapsing-remitting
multiple sclerosis were randomized to treatment with alemtuzumab at one
of two dose levels, or to the approved MS therapy Rebif® (high dose
interferon beta-1a). Alemtuzumab was given to patients in two or three
annual cycles of not more than five days per cycle, while Rebif was
given to patients three times per week, every week for three years. The
majority of alemtuzumab treated patients last received the
investigational drug at Month 12.
The trial successfully met its two primary endpoints, reduction in
relapse rate and reduction in the rate of sustained accumulation of
disability.
Patients were strongly encouraged to continue for two additional years
of follow-up beyond the original three years of the study. Sixty-eight
percent of alemtuzumab patients participated in the follow-up program,
and 60 percent were evaluated at 60 months. Forty-two percent of Rebif
patients participated in the follow-up program, and 35 percent were
evaluated at 60 months. Rater-blinded disability scores were assessed
quarterly and relapses as-needed. A sensitivity analysis adjusted for
patients receiving alternative disease-modifying therapy during the
follow-up period, as well as for retreatment with alemtuzumab.
Safety Information
As previously reported, common adverse events associated with
alemtuzumab in the CAMMS223 Phase 2 trial included mild to moderate
infusion-associated reactions, secondary autoimmunity (primarily thyroid
disorders and immune thrombocytopenia), and infections, particularly of
the upper respiratory tract; infections were predominantly mild to
moderate in severity and there were no life-threatening or fatal
infections. Approximately 30 percent of alemtuzumab-treated patients
developed an autoimmune thyroid-related adverse event. Thyroid disorders
were managed using conventional therapies. Patient monitoring for
thyroid disorders, ITP, and anti-GBM disease is incorporated into all
Genzyme-sponsored trials of alemtuzumab for the investigational
treatment of MS.
Since it is not yet approved for the treatment of MS, alemtuzumab must
not be used in MS patients outside of a formal, regulated clinical trial
setting in which appropriate patient monitoring measures are in place.
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 its founding in 1981, the company has introduced
breakthrough treatments across several areas of medicine that have
provided new hope for patients. Today, approximately 10,000 Genzyme
employees serve patients in nearly 100 countries.
Genzyme's products are focused on rare inherited disorders, kidney
disease, orthopaedics, cancer, transplant, and immune disease. The
company's commitment to innovation continues today with a substantial
development program focused on these fields, as well as cardiovascular
disease, neurodegenerative diseases, and other areas of unmet medical
need. Genzyme is part of the sanofi-aventis Group.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY).
Genzyme Forward Looking Statements
This press release contains forward-looking statements regarding
Genzyme’s future plans and business strategies, including its
expectations about when data from its two phase 3 trials for alemtuzumab
will be available and the potential success of alemtuzumab to treat MS.
These statements are subject to risks and uncertainties that could cause
actual results to differ materially from those projected in these
forward-looking statements, including: the timing and outcome of the
data from the phase 3 trials; the timing and outcome of discussions with
the regulatory agencies regarding approval of alemtuzumab for MS; the
actual safety and efficacy of alemtuzumab for MS; and the risks and
uncertainties described in Genzyme’s reports filed with the Securities
and Exchange Commission under the Securities Exchange Act of 1934,
including the factors discussed under the caption "Risk Factors" in
Genzyme's Annual Report on Form 10-K for the period ended December 31,
2010. Genzyme cautions investors not to place undue reliance on the
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Genzyme® is a registered trademark and CARE-MS is a service mark of
Genzyme Corporation. All rights reserved. Rebif® is a registered
trademark of EMD Serono, Inc. or affiliates.