New Peer Review Publications Support Nymox Saliva Smoking Test

Main Category: Smoking / Quit Smoking
Article Date: 24 Apr 2008 - 2:00 PDT

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Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced today the publication of new independent studies finding that the Company's NicAlert™ Saliva product provides an accurate, convenient and cost-effective way to verify self-reported smoking status with broad potential applications both in the clinic and in large research trials and surveys.

In the study, researchers collected saliva samples from 41 smokers and 45 nonsmokers and tested the samples with both NicAlert™ Saliva test strips and with gas chromatography (GC), a complex and sophisticated laboratory testing method in order to verify smoking status. The researchers found that NicAlert™ Saliva testing was "both valid and reliable compared with the GC saliva cotinine test" despite being one-third the cost and concluded that "studies that evaluate disease outcomes related to smoking or new smoking cessation methods should consider testing participants' saliva using [NicAlert™] to verify self-reported smoking status." They also noted that NicAlert™ Saliva has "the potential for use in large population-based trials of smoking cessation interventions, for evaluating the effectiveness of a cessation service, and in population prevalence surveys to measure rates of smoking and quitting over time" and "also may be of value in cessation practice" as a point-of-care test that can provide immediate feedback.

The study was conducted by researchers at Clinical Trials Research Unit, University of Auckland, Auckland, New Zealand and is published in the latest issue of Nicotine & Tobacco Research, the official journal of the Society for Research on Nicotine and Tobacco (SRNT) (Fiona Cooke, Chris Bullen, Robyn Whittaker, Hayden McRobbie, Mei-Hua Chen, Natalie Walker, "Diagnostic accuracy of NicAlert cotinine test strips in saliva for verifying smoking status," Nicotine Tob Res. 2008 Apr;10(4):607-12).

The study confirmed earlier published studies that found that NicAlert™ Saliva provided a rapid and convenient way of verifying smoking status without requiring elaborate and expensive laboratory facilities: Cancer Epidemiol Biomarkers Prev. 2007;16:1858-62 and Int J Circumpolar Health. 2007; 66 Suppl 1:29-38.

NicAlert™ Saliva is increasingly being reported used in a wide range of research studies where there is a need to verify or monitor smoking status or nicotine replacement therapy (NRT): see, for example, Am J Prev Med. 2007; 33:297-305 (monitoring NRT in smoking cessation research involving pregnant women), Int J Behav Med. 2006; 13:16-25 (verifying smoking status in a smoking study of cancer patients), and Neuropsychopharmacology 2008; 33:480-490 (confirming non-smoking status for entry into study).

NicAlert™ can be used with either urine or saliva samples to provide an accurate visual read-out on a person's tobacco use or exposure within minutes by measuring levels of cotinine, a by-product of the break-down of nicotine in the human body. NicAlert™ Saliva has achieved certification with the CE Mark, permitting its sale in the European Union. The urine-based version of NicAlert™ received clearance from the U.S. Food and Drug Administration and achieved certification with the CE Mark.

Cigarette smoking is the single most preventable cause of premature death in the United States. Each year, over 400,000 people die as a result of tobacco use and exposure in the U.S. alone. Experts in the field have long advocated that physicians should treat the routine assessment of smoking and other tobacco product use of patients in the clinic as an important "vital sign" for health risk reduction strategies and appropriate disease management.

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 and diagnostic 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.

Nymox Pharmaceutical Corporation