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Macro*World Investor Newron Receives US IND Approval for Safinamide in Parkinson's Disease. BRESSO, Italy, Jul 23, 2003 /PRNewswire via COMTEX/ -- Newron Pharmaceuticals SpA, a clinical-stage company focused on developing novel CNS therapies, has obtained IND (Investigational New Drug) approval from the US Food and Drug Administration (FDA) to evaluate safinamide as a treatment for Parkinson's disease. Under this IND, a protocol has been approved to assess the safety of safinamide in 12 healthy volunteers. The trial will be conducted at the University of Vienna, Austria, under the auspices of Professor Hans Georg Eichler. The FDA approved study is being conducted to confirm that no dietary restrictions are needed while being treated with safinamide. This study will shortly be followed by efficacy studies in Parkinson's disease conducted in the USA. Safinamide is currently being evaluated in multiple Phase II trials in Europe for the treatment of Parkinson's disease and epilepsy. "Obtaining FDA IND approval marks a crucial point in the development of safinamide. We have been encouraged by the positive data generated from European trials of this compound in both epilepsy and Parkinson's disease. Confirming these benefits in US clinical studies is now a priority for Newron," commented Stefano Rossetti, MD, Vice President, Clinical Development for Newron Pharmaceuticals. About Safinamide Safinamide is an investigational new drug that is being studied in Phase II clinical trials in Europe for the treatment of Parkinson's disease and epilepsy. Safinamide is a unique molecule with multiple mechanisms of action, including potent, selective and reversible inhibition of monoamine oxidase (MAO)-B, without a MAO-A effect, dopamine re-uptake inhibition, sodium channel blocking activity and calcium channel modulation. The development of safinamide in Parkinson's disease is supported by a euro 2.7 million grant from the Italian Ministry of Productive Development's Innovation Technology Fund. About Newron Pharmaceuticals Newron Pharmaceuticals SpA is a clinical stage biopharmaceutical company focused on novel ion channel-based therapies for diseases of the central nervous system (CNS), particularly epilepsy, Parkinson's disease, neurodegeneration and pain. In addition to safinamide, the company is also conducting Phase I clinical trials with ralfinamide, a potent sodium channel blocker, for the treatment of neuropathic pain. Newron's clinical pipeline is supported by a broad portfolio of early stage products fueled by the company's discovery pipeline. Newron is headquartered in Bresso, near Milan, Italy. For further information visit www.newron.com. SOURCE Newron Pharmaceuticals SpA CONTACT: Dr. Luca Benatti, CEO of Newron Pharmaceuticals, +39-02-610-3461; or Mike Sinclair, Director, Halsin Partners, +44-870-747-0880, for Newron Pharmaceuticals URL: http://www.newron.com http://www.prnewswire.com SOURCE: PR Newswire / Macro*World Investor http://www.mworld.com/m/m.w?lp=GetStory&id=68113551 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn