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| Biogen and Elan Present Promising Data for Antegren(R) (Natalizumab) in Multiple Sclerosis at Ectrims Congress |
Phase III Trials to Begin Soon
DUBLIN, Ireland, Sept. 15 /PRNewswire/ -- Antegren(R) (natalizumab), a
humanized monoclonal antibody, demonstrated promising results on multiple
endpoints in a Phase II study in multiple sclerosis (MS), according to data
presented today at the annual meeting of the European Congress on Treatment
and Research in Multiple Sclerosis (ECTRIMS). Biogen, Inc. (Nasdaq: BGEN)
("Biogen") and Elan Corporation, plc (NYSE: ELN) ("Elan") are collaborating on
the development, manufacture and marketing of Antegren, one of the first in a
new class of potential therapeutics discovered by Elan. Antegren, an alpha-4
integrin inhibitor was designed to prevent migration of inflammatory cells
from blood vessels into tissues. This pathway was pioneered by both Elan and
Biogen.
Elan conducted a Phase II, double-blind, placebo-controlled trial of
213 MS patients at 26 sites in the U.S., Canada and the U.K. Patients
received either of two Antegren doses (3 mg/kg or 6 mg/kg) or placebo by
intravenous infusion every 4 weeks for 6 months. Participants in the trial had
either relapsing-remitting MS or secondary progressive MS.
The primary analysis was based on MRI scans and showed that patients
treated with Antegren for 6 months had fewer new gadolinium-enhancing lesions
than patients treated with placebo. In the placebo group (n=71), the
cumulative mean number of new enhancing lesions during the treatment period
was 9.6, whereas the Antegren 3 mg/kg group (n=68) had a mean of 0.6 new
lesions and the Antegren 6 mg/kg group (n=74) had accumulated 1.2 new lesions
during the same period.
"The robust effects of Antegren in reducing MRI activity is promising and
suggest that the agent's mechanism of action has potential as a new approach
to treating MS. This will be investigated in further trials," said David
Miller, M.D., professor of neurology, Institute of Neurology, London, United
Kingdom.
Secondary endpoints in the study included the change in the MSFC (MS
Functional Composite) and in the EDSS (Expanded Disability Status Score) over
the treatment phase. There were no changes seen (in these parameters) in
either the placebo or treatment groups over the 6 months of treatment.
The number of MS relapses over the treatment period -- one of the
pre-specified clinical endpoints in the trial -- was also reduced, with
34 relapses in the placebo group compared to 19 in the Antegren 3 mg/kg group
and 14 in the Antegren 6 mg/kg group.
"Most neurologists would agree that we need to boost the efficacy of the
existing treatments for MS," said George Rice, M.D., professor, clinical
neurological sciences, University of Western Ontario, London, Ontario, Canada.
"Antegren may provide a new meaningful treatment option."
Antegren was generally well tolerated. The most common adverse events in
the study were headache, asthenia and urinary tract infections. Certain
adverse events occurred more commonly with Antegren compared to placebo, such
as gastroenteritis, rash, urinary urgency, back pain and fever. Additionally,
serious adverse events included infrequent hypersensitivity-like reactions.
Stephen Reingold, Ph.D., Vice President-Research of the National Multiple
Sclerosis Society, said, "The impact of Antegren on brain lesions suggests
that this agent might have a role in treatment of MS. This is important,
since the agent appears to work differently than currently available MS
treatments. The outcomes of the planned trials will be eagerly awaited."
More than one million people in North America and Europe have MS, a
chronic, often disabling, disease of the central nervous system. Symptoms
range from mild, such as numbness in the limbs, to severe, including paralysis
or loss of vision. Most people with MS are diagnosed between the ages of
20 and 40 and more women have MS than men.
Elan and Biogen are also studying the potential of Antegren in Crohn's
disease, a chronic inflammatory disease of the gastrointestinal tract.
Positive data from a Phase II trial in Crohn's disease were presented in May
at the annual meeting of the American Gastroenterological Association during
Digestive Disease Week. In that trial, a clinical response (decrease of >70
points in the Crohn's disease Activity Index (CDAI)) was achieved in 74% of
patients in the Antegren 3 mg/kg group (n= 65) versus 38% of patients in the
placebo group (n=63). Furthermore, remission, defined as a CDAI score of <150
was achieved by 46% of patients in the 3mg/kg dose group versus 27% in the
placebo group. In the Crohn's disease trial, Antegren was generally well
tolerated. Data suggest that the most common adverse events reported were
headache and abdominal pain. There were no notable differences among
treatment groups in the number of patients reporting side effects.
Based on the positive Phase II findings in MS and Crohn's disease, the
companies intend to move the unique compound into Phase III studies in both
indications by the end of this year. The companies are planning to start two
Phase III studies in MS, studying Antegren as a monotherapy, as well as in
combination with Biogen's Avonex(R) (Interferon beta-1a).
Antegren is designed to block immune cell adhesion to blood vessel walls
and subsequent migration of lymphocytes into tissue. Antegren was discovered
in Elan's research facilities in South San Francisco, and both Elan and Biogen
have pioneered research into this unique pathway. Antegren binds to the cell
surface receptors known as alpha-4-beta-1 (VLA-4) and alpha-4-beta-7.
Antegren may be useful in the treatment of a range of autoimmune diseases, in
addition to MS and Crohn's disease. The companies intend to pursue clinical
studies of Antegren in other autoimmune diseases.
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biopharmaceutical company principally engaged in discovering and developing
drugs for human healthcare through genetic engineering. Headquartered in
Cambridge, MA, the Company's revenues are generated from international sales
of AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of multiple
sclerosis, and from the worldwide sales by licensees of a number of products,
including alpha interferon and hepatitis B vaccines and diagnostic products.
More than 100,000 patients throughout the world take Biogen's drug, AVONEX(R)
(Interferon beta-1a), the world's leading therapy for relapsing forms of
multiple sclerosis. (Please see full prescribing information at
http://www.avonex.com) Biogen's research and development activities are
focused on novel products to treat inflammatory and autoimmune diseases,
neurological diseases, cancer, fibrosis and congestive heart failure. The
Company maintains active clinical research programs in protein therapeutics,
small molecules, genomics and gene therapy. For copies of press releases and
additional information about the Company, please consult Biogen's Homepage on
the World Wide Web at http://www.biogen.com.
Elan Corporation, plc is a leading worldwide, fully integrated
pharmaceutical company headquartered in Ireland, with its principal research,
development, manufacturing and marketing facilities located in Ireland, the
United States and the United Kingdom. Elan is focused on the discovery,
development and marketing of therapeutic products and services in neurology,
pain management, oncology, infectious disease and dermatology and on the
development and commercialization of products using its extensive range of
proprietary drug delivery technologies. Elan shares trade on the New York,
London and Dublin stock exchanges.
In addition to historical information, this press release contains
forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995. Reference is made in
particular to statements regarding the potential for Antegren as a therapeutic
product and the anticipated commencement of Phase III trials. These statements
are based on the companies' current beliefs and expectations as to such future
outcomes. Drug development involves a high degree of risk. Success in early
stage clinical trials does not ensure that later stage or larger scale
clinical trials will be successful. Factors which could cause actual results
to differ materially from the companies' current expectations include the risk
that problems or delays may arise during preparations for clinical trials or
in the course of development, testing or manufacturing of the product, that
results in later stage or larger trials may be different than those seen in
earlier stage trials or that the product may not show therapeutic effect or an
acceptable safety profile in subsequent trials or may not meet applicable
regulatory standards as well as the other risks and uncertainties described
from time to time in the companies' periodic reports filed with the Securities
and Exchange Commission.
SOURCE Elan Corporation
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