Nymox’s NicAlert(TM) Gains Acceptance in Clinical Trials and Research Studies
Nymox Pharmaceutical Corporation’s (NASDAQ: NYMX) NicAlert(TM) product has gained acceptance as an important tool in research studies and clinical trials where it is important to know the level of tobacco use or exposure among participants. Recent peer-reviewed publications of studies involving NicAlert(TM) include BMC Oral Health (June, 2008; 3; 8:18) (large scale study of oral health in Appalachia), Biol Psychiatry (June 2008; 63:1061-1065) (psychological effects of nicotine administered to nonsmokers), Psychopharma-cology (Berl) (July, 2008;199:89-98) and Neuropsychopharmacology (February 2008; 33:480-490) (cognitive effects of nicotine administered to nonsmokers), Am J Prev Med. (2007; 33:297-305) (monitoring NRT in smoking cessation research involving pregnant women), and Int J Behav Med. (2006; 13:16-25) (study of smoking rates in cancer patients). Many research institutions use NicAlert(TM) such as Harvard and the NIH.
The urine-based version of NicAlert(TM) received clearance from the U.S. Food and Drug Administration to measure tobacco use and exposure and achieved certification for sale in the European Union with the CE Mark. The saliva-based version of NicAlert(TM) has achieved certification with the CE Mark, permitting its sale in the European Union. TobacAlert(TM) which employs the same technology is available for non-medical use as an over-the counter product in the U.S. for detecting second-hand smoke exposure using urine samples.
“NicAlert(TM) offers tremendous advantages for companies, universities, hospitals and research institutions with the need to screen prospective research subjects for their smoking status or level of tobacco use or exposure,” said Brian Doyle, Nymox’s Director of Business Development. “NicAlert(TM) testing is simple and convenient, does not require special training, and can deliver highly accurate results on site in a matter of minutes. This allows for the rapid screening of potential subjects, saving time and expense for all concerned. On-site NicAlert(TM) testing helps avoid the situation where the study site has gone through the whole screening process for a potential subject only to find out hours or days later from the lab results come back that the subject does not qualify for the study.”
NicAlert(TM) employs Nymox’s proprietary technology to measure levels of cotinine, a metabolite of nicotine widely used to determine tobacco product use and second-hand smoke exposure. The product requires no instruments for its use and provides an on-site visual read-out of the level of tobacco use or exposure within minutes.
The studies where NicAlert(TM) has application range from nicotine research, smoking cessation studies and clinical trials for investigational drugs where tobacco can affect performance, indications such as asthma, where only non-smokers are sought or where it is important to know a subject’s true baseline smoking status or tobacco product exposure.
Independent studies have confirmed the accuracy and effectiveness of Nymox’s testing technology. Researchers at the Centers for Disease Control and Prevention (CDC) authored a study in the peer-review literature using NicAlert(TM) (Journal of Analytical Toxicology 2005; 29: 814-818) and found that NicAlert(TM) measurements correlated well with the far more complex laboratory testing (liquid chromatography-mass spectrometry) used in the CDC laboratory. Other independent peer-reviewed studies have also found the technology employed in NicAlert(TM) to be accurate, rapid and cost-effective (Cancer Epidemiology, Biomarkers & Prevention 2002; 11:1123-1125; Nicotine & Tobacco Research 2002; 4:305-9). A recently published independent study reported positive data on the accuracy and usefulness of NicAlert(TM) testing for tobacco exposure using saliva samples in a family practice setting (Cancer Epidemiology, Biomarkers & Prevention 2007; 16:1858-62).
NicAlert(TM) comes in two formats: NicAlert(TM) Saliva which uses saliva samples for verifying smoking status and measuring high levels of consumption and NicAlert(TM) Urine which uses urine samples and can provide data not only on smoking status but also second-hand smoke exposure and levels of tobacco product use.
More information about Nymox is available at www.nymox.com, email: email@example.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. Such factors are detailed from time to time in Nymox’s filings with the United States Securities and Exchange Commission and other regulatory authorities.