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Nymox Files PMA Amendment with FDA for Alzheimer Urine Test.

MAYWOOD, N.J. -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today that it has filed an amendment to its Premarket Approval application (PMA) for the Company's urine NTP test kit with the FDA. The PMA amendment was filed in response to the Company's discussions and meetings with the FDA. The Company believes that the remaining requirements from the Company's meetings and discussions with the FDA will be completed and filed in the next 30 to 60 days.

The urine NTP test kit is a kit version of the Company's AlzheimAlert(TM) test and is designed for sale to clinical laboratories and hospitals for on-site testing of patient urine samples using the kit.

The NTP test is a non-invasive urine test intended to help physicians in the diagnosis of Alzheimer's disease. The test measures the level of a brain protein called neural thread protein (NTP) known to be elevated in the urine of patients with Alzheimer's disease. There is an extensive scientific and medical literature on NTP and its relationship to Alzheimer's disease and on its clinical accuracy and utility as an aid to the diagnosis of Alzheimer's disease. Publications include, for example, Journal of Alzheimer's Disease (2004; 6(3): 231-42) and (2001; 3: 345-353); Cellular and Molecular Life Sciences (2003; 60: 2679-91) and (2001; 58: 844-849); Alzheimer's Reports (2002; 1: 1-6); Neurology & Clinical Neurophysiology (2002; 1: 2-7); Frontiers in Bioscience (2002; 7:d989-96); Journal of Neuropathology and Experimental Neurology (2001; 60: 195-207) and (1996; 55: 1038-1050); Neurology (2000; 55: 1068) and (2000; 54: 1498-1504); Alzheimer's Reports (2001; 4: 61-65), (2000; 3: 177-184) and (1999; 2: 327-332); Journal of Clinical Laboratory Analysis (1998; 12: 285-288) and (1998; 12: 223-226); Journal of Contemporary Neurology (1998; 4A: 2-6); and Journal of Clinical Investigation (1997; 100: 3093-3104).

More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.

This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
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Publication:Business Wire
Geographic Code:1CANA
Date:Nov 4, 2004
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