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Clinical Trial Investigates Treatment of Multiple Sclerosis With Gamunex

RESEARCH TRIANGLE PARK, N.C., May 11 /PRNewswire/ -- Bayer HealthCare LLC, Biological Products Division (Bayer BP), has closed enrollment in the first industry-sponsored trial to evaluate immune globulin intravenous (IGIV) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under an Investigational New Drug application (IND) submitted to the U.S. Food and Drug Administration (FDA), the multi-national clinical trial will assess the efficacy and safety of Gamunex®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, in RRMS. The study includes 120 patients participating from many regions of the world, including North America, eastern and western Europe, and Israel.

Other data in this field, including published studies, point to IGIV as potentially effective in the treatment of RRMS. Most recently, a retrospective analysis of 300 patient medical records conducted in Germany and Austria documented use of IGIV in the treatment of RRMS. The analysis showed IGIV significantly reduced the annual relapse rate by 69 percent compared with the two years prior without IGIV treatment. In addition, a meta-analysis of four randomized, placebo-controlled trials of IGIV in patients with RRMS conducted in Europe and published in the journal Neurological Sciences in 2003 showed positive results for primary endpoints, including relapse rate, new MRI lesions, and disease progression. The author concluded IGIV is an alternative second-line treatment to approved therapies in relapsing-remitting MS, but the ideal dosage of IGIV still needs to be determined.

Multiple sclerosis affects 4.5 million people worldwide. While the cause of MS is unknown, it is considered to be an autoimmune disease affecting the central nervous system. Though a number of therapies for MS have become available during the past decade, additional treatment options are needed for those who still experience relapses. None of the FDA-approved therapies cure MS and all require injections on a daily to weekly basis. In RRMS, patients relapse and experience episodes of impaired neurological function. Relapses are followed by partial or complete remissions without symptoms. RRMS is the most common form of MS, affecting 85 percent of all patients at the time of initial diagnosis.

"Although there are approved therapies that reduce the frequency of relapses in RRMS patients, they only are partially effective and require, at least, weekly injections," said lead investigator, Fred D. Lublin, M.D., director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology, Mount Sinai School of Medicine, New York. "This study will determine whether monthly Gamunex infusions are a viable therapy option for RRMS patients."

Bayer's current clinical trial is a randomized, double-blind, placebo- controlled design and compares patients receiving Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, at two different doses to determine if a marked reduction in relapses of their disease occurs. The trial includes people 18 to 55 years old who have had RRMS for up to five years and have not received treatment with other approved MS therapies or IGIV within the past three months. The study began in December 2002 and is expected to conclude in 2005.

Each vial of Gamunex contains antibodies purified from the donated blood plasma of thousands of people and can be a lifesaving anti-infective or immunomodulatory therapy to treat people with compromised or malfunctioning immune systems. Gamunex is indicated for the treatment of patients with primary humoral immune deficiency (PI)(a), a group of diseases caused by genetic defects in the immune system. Gamunex also is indicated for the acute and chronic treatment of idiopathic thrombocytopenia purpura (ITP), an autoimmune condition characterized by a low platelet count, leading to occasional life-threatening bleeding episodes. The most common side effects noted during clinical trials for PI and ITP included headache, vomiting, fever, nausea, rash, and back pain.

In addition to the RRMS studies, Bayer also has invested in the development of clinical studies in other neurological disorders, such as chronic inflammatory demyelinating polyneuropathy (CIDP). For additional information about the ongoing trials using Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, or for full prescribing information, visit http://www.gamunex.com/.

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