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Advocate Peggy Willocks was in the original Spheramine trial. Ray SpheramineŽ Spheramine is a novel cell therapy product in development for the treatment of Parkinson's disease, a neurodegenerative disorder that affects over four million individuals world wide. Parkinson's disease results from declining levels of dopamine production and associated neuronal activity in specific regions of the brain. Symptoms include tremor, rigidity, and slowness of normal voluntary movement. Current treatments involve daily administration of oral agents containing dopamine precursors or dopamine agonists which raise the levels of dopamine activity in the brain. However, most patients eventually develop a "wearing-off effect" where each dose alleviates symptoms for a shorter amount of time. Because these therapies are orally delivered, they also result in elevated systemic levels of dopamine, causing potential side effects. Spheramine is an innovative, standardized cell therapy using normal human cells. These cells, retinal pigment epithelial (RPE) cells, are placed on microcarriers and injected into the brain to provide a localized continuous source of dopamine in brain regions deficient in dopamine. Titan is developing Spheramine in partnership with Bayer Schering Pharma AG for the treatment of advanced Parkinson's disease. Spheramine utilizes Titan's novel, cell-coated micro-carrier (CCMT) technology that enables minimally-invasive, site specific delivery of therapeutics to the central nervous system. CCM technology involves adhering cells to microscopic beads that enable the survival of the cells in the central nervous system. CCM technology also avoids the need for immunosuppression (suppression of the immune system to prevent rejection.) Positive results from a pilot clinical study to assess the safety and preliminary efficacy of Spheramine in six subjects with moderately severe to severe Parkinson's disease, demonstrated an average improvement in motor function of 48% over baseline at one-year post treatment. Data was presented at the International Congress on Parkinson's disease in June 2005 demonstrating continuing average improvement in motor function of 40% in these patients, four years after treatment. Based on the encouraging results from the pilot study, Titan and Bayer Schering Pharma AG initiated a 68-patient, randomized, double blind, controlled Phase IIb clinical study to further evaluate the safety and efficacy of Spheramine. Enrollment in the study is complete with a total of 71 patients treated. Results from the study are expected to be available in the third quarter of 2008. The FDA has granted Fast Track designation for Spheramine. The FDA's Fast Track Program is designed to facilitate the development and expedite the review of drug candidates that demonstrate the potential to treat serious or life-threatening diseases and address unmet medical needs. The FDA has also approved Orphan Drug designation for Spheramine for the treatment of advanced Parkinson's disease. from Viartis Parkinson's Disease News site Rayilyn Brown Board Member AZNPF Arizona Chapter National Parkinson's Foundation [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn