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DUBLIN, Ireland and CAMBRIDGE, Mass., Dec. 18 /PRNewswire/ -- Elan Corporation, plc (NYSE: ELN) ("Elan") and Biogen, Inc. (Nasdaq: BGEN) ("Biogen") announced today that they have enrolled and dosed the first patients in their multi-center Phase III clinical trials of Antegren(R) (natalizumab) in multiple sclerosis ("MS"). Elan and Biogen expect to enroll and dose the first patients in their Phase III clinical trials for Crohn's disease before year-end.
Biogen and Elan are collaborating on two trials in MS. The AFFIRM (Antegren safety and efficacy in relapsing-remitting MS) trial is a two year, randomized, multi-center, placebo-controlled, double blind study of approximately 900 patients, designed to determine whether Antegren is effective in slowing the rate of disability in MS and reducing the rate of clinical relapses. The second trial, known as SENTINEL (safety and efficacy of natalizumab in combination with Avonex(R) (Interferon beta-1a) in subjects with relapsing-remitting MS), is a two year, randomized, multi-center, placebo-controlled, double blind study of approximately 1,200 patients. The SENTINEL trial, which will be one of the largest conducted in MS, is designed to determine whether the treatment of MS with Antegren in combination with Avonex is more effective than Avonex treatment alone in slowing the rate of disability in MS and in reducing the rate of clinical relapses.
Elan and Biogen are also conducting two Phase III clinical trials in Crohn's disease. The first Phase III trial, the largest to be conducted in Crohn's disease, is a randomized, multi-center, placebo-controlled, double blind study of approximately 850 patients, which is designed to measure both the response and the ability to induce remission in patients at week 10 of administration of Antegren. The second randomized, multi-center, placebo controlled, double blind Phase III trial of approximately 300 patients is designed to evaluate the effect of Antegren on the duration of response and remission in patients with Crohn's disease.
Compelling Data Seen in Phase II MS Trial
In September 2001, Biogen and Elan presented promising data from the Phase II trial of Antegren in MS at the annual meeting of the European Congress on Treatment and Research in Multiple Sclerosis. This was a double blind, placebo-controlled trial of 213 patients who had relapsing forms of MS.
The primary analysis was based on magnetic resonance imaging ("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, while 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.
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.
Promising Crohn's Disease Data Seen in Phase II Trial
Elan and Biogen presented positive data from a Phase II trial in Crohn's disease 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). Remission, defined as a CDAI score of less than or equal to 150, was achieved by 46% of patients in the Antegren 3 mg/kg dose group versus 27% in the placebo group.
Tolerability
Antegren was generally well tolerated
by patients in both the MS and Crohn's disease studies. The most
common adverse events were headache, asthenia and urinary tract infections
(in patients with MS) and headache and abdominal pain (in patients with
Crohn's disease). 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.
Mechanism of Action
Antegren, the first of a revolutionary
new class of compounds known as selective adhesion molecule inhibitors,
is designed to selectively 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 integrins, which are believed to play an important role
in the trafficking of mononuclear cells, such as lymphocytes, into sites
of inflammation. 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) 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), 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 biopharmaceutical 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 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. For copies of
press releases and additional information about the company, please consult
Elan's homepage on the worldwide web at http://www.elan.ie
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 Companies'
future development plans. 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 expectation include the
risk that the product may not show therapeutic effect or an acceptable
safety profile in subsequent trials or may not meet applicable regulatory
standards, or that problems or delays may arise during clinical trials
or in the course of the development, testing or manufacturing of the product
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.
Elan Corporation, plc and Biogen,
Inc.
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SOURCE
Web Site:
http://www.elan.ie
http://www.avonex.com
http://www.biogen.com