SOURCE: Elan Corporation, plc and Biogen, Inc.
Elan and Biogen Begin Phase III Clinical Trials of Antegren(R) (Natalizumab) In Multiple Sclerosis and Crohn's Disease
DUBLIN, Ireland and CAMBRIDGE, Mass., Dec. 18 /PRNewswire/ -- Elan Corporation, plc (NYSE: ELN - news; ``Elan'') and Biogen, Inc. (Nasdaq: BGEN - news; ``Biogen'') announced today that they have enrolled and dosed the first patients in their multi-center Phase III clinical trials of Antegren® (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® (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® 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®, the world's leading therapy for relapsing forms of multiple sclerosis. (Please see full prescribing information at 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 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 elan.com.
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