BGEN (and ELN) pipeline fills a little more with some encouraging Antegren results:
Note the "high degree of statistical significance" in MS. Difficult to achieve in only 200-odd patients because of the highly variable nature of the disease.
Monday January 22, 4:46 pm Eastern Time
Press Release
SOURCE: Biogen, Inc.
Elan and Biogen Announce Positive Phase II Results for Antegren(R) (Natalizumab) in Multiple Sclerosis and Crohn's Disease
Companies to Move to Phase III Trials
CAMBRIDGE, Mass., and DUBLIN, Ireland, Jan. 22 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN - news) and Elan Corporation, plc (NYSE: ELN - news) announced today positive results from preliminary analyses of two large Phase II clinical studies with Antegren® (natalizumab) in multiple sclerosis (MS) and Crohn's Disease. The companies are now proceeding to initiate Phase III clinical studies in 2001 in both these diseases.
(Photo: newscom.com )
The first of the studies conducted was a Phase II double-blind placebo controlled trial which included 213 MS patients at 26 sites in the U.S., Canada and the U.K. Patients received monthly doses of Antegren or placebo over a six-month period. The primary endpoint of a reduction in new gadolinium enhancing lesions compared to placebo over the 6-month treatment period was achieved with a high degree of statistical significance.
A separate Phase II double-blind placebo controlled study conducted across 38 sites in 8 European countries included 240 patients with moderate to severe Crohn's Disease. Patients received doses of Antegren or placebo at week 0 and week 4. This study also demonstrated statistically significant positive results on multiple endpoints, including induction of remission as measured by the Crohn's Disease Activity Index.
Further information about the potential safety and efficacy of the drug will be presented at a scientific conference later this year. The companies will be conferring with regulatory authorities about next steps in the drug's development. Antegren has now been evaluated in approximately 600 patients in 10 clinical studies.
James C. Mullen, Biogen's president and chief executive officer, said, ``As a biotechnology company committed to developing breakthrough therapies for people with serious diseases, we are very excited about these results. With approximately one million MS patients worldwide, we believe that Antegren, used alone or in combination with Avonex® (Interferon beta-1a), should allow us to offer more solutions to a broader range of MS patients than are currently available. For the 300,000 patients with moderate-severe Crohn's Disease, Antegren offers a potential novel treatment approach for this patient population.''
Donal J. Geaney, Elan's chairman and chief executive officer, said, ``We are delighted that these positive results support the continued and accelerated development of Antegren as a potentially important new therapy for the treatment of MS and Crohn's disease. In conjunction with Biogen, we look forward to advancing Antegren into Phase III studies.''
In August 2000, Biogen and Elan announced a worldwide, exclusive collaboration to develop, manufacture, and commercialize Antegren. Antegren, which was discovered by Elan, is a humanized monoclonal antibody and the first in a new class of potential therapeutics known as alpha 4 integrin inhibitors that are designed to block immune cell adhesion to blood vessel walls and subsequent migration of lymphocytes into tissue. 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 inflammatory and non- inflammatory diseases. Both Elan and Biogen are pioneers in the study of this pathway.
Peter |
