Biohit Oyj Stock Exchange Release November 4, 2015 at 9:30 a.m. local time (EET)
The smoking intervention study of Biohit Oyj of nearly two years of duration using Acetium lozenge has been completed. Acetium lozenge is used to bind cigarette-smoke derived acetaldehyde in the saliva into a harmless compound, in addition to its beneficial effects on oral health. According to some preliminary observations, the Acetium lozenge is considered to be a promising novel intervention method to assist in smoking cessation.
Biohit Oyj started a randomized, double-blind trial in late 2013 (Biohit Oyj to start a clinical intervention trial with Acetium® lozenge aimed at smoking cessation, November 29, 2013), in which the effectiveness of Acetium lozenge was studied in a new indication i.e., to help with smoking cessation. Results of the study were evaluated according to how many study subjects quit smoking and how long was the duration of their smoking abstinence.
The study was based on a novel hypothesis that acetaldehyde, in addition to nicotine, is a significant factor maintaining smoking dependence (1). Acetaldehyde dissolved into saliva during smoking, might act with certain natural amino acids to form condensation compounds called Harmans. These inhibit monoamine oxidase (MAO) – an enzyme in the central nervous system, which plays a key role in mediating the rewarding effects of smoking in the brain. It has been suggested that cigarette smoke-derived acetaldehyde has reinforcing effects on nicotine addiction and thereby help maintaining the behavioural sensitization to tobacco. Blood Harman levels among smokers are 2-10 times higher than in non-smokers (1). It was reasoned that an effective elimination of acetaldehyde in the saliva (2) could interfere with this reaction by using the Acetium lozenge.
A cohort of 423 smokers volunteered in the study and they were randomly allocated into two groups of equal size. Of these two study arms, one group used Acetium lozenge during smoking and the other used placebo in a double-blind setting. The results were analysed separately for the study subjects who followed the protocol to perfection, and for those who did so with minor violations.
The principal investigator, Chief Medical Director of Biohit Oyj, Professor Kari Syrjänen: ‘Regardless the mode of data analysis, the Acetium lozenge was more effective than placebo as a trigger for quitting smoking. In the intervention group, 42.9 % could stop smoking as compared to 31.1% in the placebo group (i.e. Acetium was 37.9% more effective). Compared to the placebo, the likelihood of smoking cessation among Acetium users during the trial was up to1.65-fold (i.e., 65% higher probability). This figure favourably competes with those reported in large international studies for nicotine replacement therapy (NRT) (3). If confirmed in adequately powered studies (approximately 1500 smokers will be required), these result represents a breakthrough in the development of smoking intervention methods.’
CEO Semi Korpela, Biohit Oyj: 'Unlike many commonly used current intervention methods, causing severe side effects (some medical treatment) or maintaining the nicotine addiction in different forms (e.g. nicotine gums and -patches), the Acetium lozenge is a product, which has no known side effects. For this reason, there are no restrictions for use or a maximum allowable dosage, and a smoker can use it simultaneously with cigarettes until making the decision to quit smoking. Regardless of the techniques used, the decision to quit smoking, however, has to be made in person. Despite the fact that Acetium lozenge efficiently binds carcinogenic acetaldehyde dissolved into saliva from cigarette smoke, transforming it into a harmless compound, and in addition, promotes oral health (unlike the currently available medications and nicotine products), Biohit Oyj recommends quitting the smoking because of its health hazards.’
Study Protocol: http://www.biohithealthcare.com/resource/files/research/protocol-acetium-smoking-quit.pdf
References:
1. Talhout R, Opperhuizen A, van Amsterdam JG. Role of acetaldehyde in tobacco smoke addiction. Eur Neuropsychopharmacol 2007;17:627-636.
2. Salaspuro VJ, Hietala JM, Marvola ML, Salaspuro MP. Eliminating carcinogenic acetaldehyde by cysteine from saliva during smoking. Cancer Epidemiol Biomarkers Prev 2006;15:146-149.
3. Lemmens V, Oenema A, Klepp KI, Brug J. Effectiveness of smoking cessation interventions among adults: a systematic review of reviews. Eur J Cancer Prev 2008;17:535–544.
Additional information:
Chief Medical Director of Biohit Oyj, Professor Kari Syrjänen
kari.syrjanen@biohit.fi
CEO Semi Korpela, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com
Biohit in brief
Biohit Oyj is a globally operating Finnish biotechnology company. Biohit’s mission is “Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit's Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com