New TYSABRI(R) Data to Be Presented at the European Committee for Treatment and Research in Multiple Sclerosis.Study Shows Increased Proportion of Patients Achieve Disease-Free Status with TYSABRI Separate Study Demonstrates Plasma Exchange May Be an Effective Tool to Accelerate TYSABRI Removal PRAGUE, Czech Republic -- Biogen Idec (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BIIB BIIB Basic Imagery Interpretation Brief ) and Elan Corporation, plc (NYSE NYSE See: New York Stock Exchange : ELN Noun 1. ELN - a Marxist terrorist group formed in 1963 by Colombian intellectuals who were inspired by the Cuban Revolution; responsible for a campaign of mass kidnappings and resistance to the government's efforts to stop the drug trade; "ELN kidnappers target ) announced that TYSABRI([R]) (natalizumab) treatment significantly increases the proportion of disease-free patients with multiple sclerosis (MS) according to a post hoc analysis of the Phase III AFFIRM study to be presented on Saturday, October 13, 2007 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS ECTRIMS European Committee for Treatment and Research in Multiple Sclerosis ) in Prague, Czech Republic. Also to be presented on Saturday will be findings from the PLEX PLEX Programming Language for Exchanges PLEX Plans and Exercises PLEX Planet Extreme (Russian gaming site) PLEX Procedure Language Extension study which suggest that plasma exchange may be an effective means of accelerating the removal of TYSABRI from the circulation. Post Hoc Analysis of Phase III AFFIRM Study The proportion of disease-free patients in the AFFIRM study was determined based upon clinical and MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. criteria. The proportion of disease-free patients over two years was significantly higher in the TYSABRI-treated group compared with the placebo group regardless of how disease free was defined. Clinically, disease free was defined as no relapses and no progression of disability (as defined by [greater than or equal to]1.0-point increase in Expanded Disability Status Scale The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.[1] The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. (EDSS EDSS Expanded Disability Status Scale EDSS Equine Digit Support System EDSS Executive Decision Support System EDSS Equipment Deployment and Storage System EDSS Electronic Document Storage System EDSS Electronic Data Storage System EDSS Electronic Document Submission System ) score from a baseline score of [greater than or equal to]1.0, or a [greater than or equal to]1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years. MRI disease free was defined as no gadolinium-enhancing lesions and no new or enlarging T2-hyperintense lesions. Using clinical and MRI disease-free criteria combined, the most stringent definition of disease free, 36.7% of TYSABRI-treated patients had no relapses, disability progression or MRI activity compared with 7.2% of placebo patients (p<0.0001). In the clinical analysis, 64.3% of TYSABRI-treated patients vs. 38.9% placebo-treated patients(p<0.0001) were disease free or without relapses and disability progression. Using MRI measures, 57.7% of TYSABRI-treated patients vs. 14.2% placebo-treated patients (p<0.0001); were disease free, or without gadolinium-enhancing lesions and new or enlarging T2-hyperintense lesions. "These data demonstrate the dramatic effect TYSABRI can have on critical measures of multiple sclerosis. In addition to the impact on individual clinical and MRI outcomes, it is striking that more than one-third of patients were free of relapses, disability progression and MRI activity after two years of treatment. This suggests that TYSABRI may offer patients freedom from many of their MS symptoms," said Eva Havrdova, MD, PhD, Director of the Center for Demyelinating Diseases at the First School of Medicine, General University Hospital, Charles University, Prague, Czech Republic. PLEX Plasma Exchange Study Results from the PLEX study also to be presented suggest that plasma exchange may be an effective means of accelerating the removal of TYSABRI from blood serum Blood serum A component of blood. Mentioned in: Bites and Stings blood serum the residual fluid of blood after clotting has occurred. It is plasma after the fibrinogen has been removed. . Plasma exchange is one of several research efforts the companies have underway to learn more about potential interventions or treatments for progressive multifocal leukoencephalopathy Progressive Multifocal Leukoencephalopathy Definition Progressive multifocal leukoencephalopathy (PML) is a rapidly progressive neuromuscular disease caused by opportunistic infection of brain cells (oligodendrocytes and astrocytes) by the JC virus (PML PML - Parallel ML. ["Synchronous Operations as First-Class Values", J.H. Reppy <jhr@research.att.com>, Proc SIGPLAN 88 Conf Prog Lang Design and Impl, June 1988, pp. 250-259]. ), a rare side effect of TYSABRI. "These data from the PLEX study are encouraging as they show the removal of TYSABRI is faster following plasma exchange. Time will tell whether plasma exchange develops as an effective treatment approach for PML," said Bhupendra O. Khatri, MD, Medical Director of the Regional MS Center, Aurora St. Luke's Medical Center, Milwaukee, WI. PLEX is an open-label, single-arm, multicenter exploratory study involving 12 patients with relapsing-remitting MS designed to explore whether plasma exchange could significantly reduce the concentration of TYSABRI in blood serum and alpha 4-integrin receptor saturation. Based on the PLEX findings, plasma exchange was effective at accelerating the normal decline of serum TYSABRI concentrations. Plasma exchange was generally well tolerated with no increase in MS disease activity following plasma exchange. There were no study discontinuations due to adverse events and all patients returned to TYSABRI treatment without complications. Further investigations are needed to determine whether plasma exchange holds promise as an intervention in the setting of PML. About TYSABRI TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . According to data that have been published in the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. , after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001). TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection viral infection, n an infection by a pathogenic virus. A virus acts on the cell nucleus, taking over the genetic material within the nucleus and replicating itself. of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. ) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants immunosuppressants, n.pl the agents that lower or reduce immune response; useful in organ transplant surgery to prevent organ rejection. Corticosteroid hormones given in large amounts; cytotoxic drugs, including antimetabolites and alkylating agents; . Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash. In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia, New Zealand and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec. For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255. About Biogen Idec Biogen Idec creates new standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com. About Elan Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com. Safe Harbor/Forward-Looking Statements This press release contains forward-looking statements regarding TYSABRI and the PLEX study. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. |
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