Phase II Clinical study establishes effectiveness of LecTec's non-nicotine pill at assisting people to stop smoking.MINNETONKA, Minn.--(BUSINESS WIRE)--April 17, 1995--LecTec Corp. today announced that its non-nicotine smoking cessation smoking cessation Public health Temporary or permanent halting of habitual cigarette smoking; withdrawal therapies–eg, hypnosis, psychotherapy, group counseling, exposing smokers to Pts with terminal lung CA and nicotine chewing gum are often ineffective. pill has been found to be effective at assisting smokers to quit by alleviating tobacco withdrawal symptoms Withdrawal symptoms A group of physical or mental symptoms that may occur when a person suddenly stops using a drug to which he or she has become dependent. , based on findings from its recently completed Phase II Clinical study. Results from this random, double-blinded study conducted at the Veterans Administration Hospital in Baltimore indicate that a significant number of outpatients using the LecTec pill abstained from smoking during the study. In contrast, most participants in the placebo group resumed smoking within a few days from the beginning of the study. Cotinine cotinine (kō´tinēn), n a substance that remains in body fluids after nicotine has been used. Presence of this chemical in body fluids is considered proof of recent nicotine use. , a natural metabolite metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food. of nicotine, is the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. in LecTec's pill that alleviates tobacco withdrawal symptoms. The Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I completed last fall established that cotinine is safe and non-toxic. Recently released preliminary findings from an ongoing study by the Addiction Research Center (ARC) of the National Institute of Drug Abuse found that cotinine has very low potential for addictiveness. The ARC findings also indicated cotinine could be an effective aid to help smokers withdraw from tobacco use. Dr. Thomas E. Brunelle, LecTec's chairman, president and chief executive officer, said the company believes its non-nicotine pill could be a viable alternative to nicotine-based products currently on the market. Supported by the positive results of LecTec's Phase I and II clinical trials, along with the preliminary findings of the ARC study, Brunelle said the company may be able to expedite the Food and Drug Administration's review and registration process that is required for commercial marketing of the product. U.S. and international patents for this particular cotinine application have been filed. LecTec holds exclusive worldwide development, licensing and marketing rights for this product. The company plans to sponsor further clinical studies this year to measure the efficacy of cotinine on a large, demographically diverse outpatient population. The company will also move ahead aggressively in regulatory and marketing activities on the non-nicotine smoking cessation pill. LecTec develops, manufactures and markets diagnostic and monitoring electrodes, medical tape and a growing range of therapeutic products. LecTec common stock is traded on the NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on National Market System under the symbol LECT lect n. A social or regional variety of speech having a sociolinguistic or functional identity within a speech community. [From (dia)lect.] . CONTACT: LecTec Corp., Minnetonka Erwin W. Templin II 612/933-2291 Fax: 612/933-4808 |
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