Today's Date: July 31, 2010

Autoimmune diseases

TYSABRI

TYSABRI (natalizumab) is a humanized monoclonal antibody and is the first alpha-4 antagonist in its class. The drug was designed to selectively inhibit immune cells from leaving the bloodstream and to prevent these cells from migrating into chronically inflamed tissue – the brain in multiple sclerosis and the gastrointestinal tract in Crohn's disease – where they may cause or maintain inflammation. To date, more than 4,000 patients have participated in natalizumab clinical studies.

Ongoing clinical trials of TYSABRI include:

  • STRATA (Natalizumab re-initiation of dosing) will evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab (during the first 48 weeks) and assess the long-term efficacy of natalizumab (for an additional 216 weeks).

  • TOP (TYSABRI observational program) is a five-year observational study to evaluate the long term safety and treatment impact of TYSABRI in patients in the commercial setting.

  • TYGRIS (TYSABRI global observational program in safety) is a 5-year, worldwide study to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients with multiple sclerosis treated with TYSABRI (natalizumab).

  • CD INFORM is an observational study to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse events in moderate to severely active Crohn's disease patients treated with TYSABRI in a commercial setting.

  • Oncology: The study of natalizumab in relapsed/refractory multiple myeloma follows preclinical data that supported the evaluation of natalizumab in oncology as a single agent or in combination with standard anti-cancer therapies.

Important Safety Information for Crohn's Disease

Important Safety Information for Multiple Sclerosis

 

Additional Autoimmune Clinical Trials

ELND002 is a subcutaneous injectable therapeutic currently in Phase 1 for relapsing forms of multiple sclerosis.

ELND004 is an orally available small molecule therapeutic currently in Phase 1 and being developed for ulcerative colitis and Crohn’s disease

Please visit clinicaltrials.gov for more information about Elan's clinical trials.