Biohit Oyj starts a confirmatory smoking intervention trial
Biohit Oyj Press Release February 15, 2016 at 9:30 am local time (EET)
Biohit Oyj starts a confirmatory clinical trial for smoking intervention in cooperation with research agency Kuulas Helsinki. The aim of the study is to confirm the promising results obtained in the previous clinical trial aimed at smoking cessation. If successful, the trial gives adequate power to confirm, that the Acetium lozenge is a breakthrough in the development of smoking intervention methods.
Biohit Oyj implemented a clinical smoking intervention trial in 2013–2015. The study was based on a hypothesis that acetaldehyde, in addition to nicotine, is a significant factor causing and maintaining smoking dependence (1). Acetaldehyde dissolved into saliva from cigarette smoke, 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 behavioral sensitization to tobacco. Blood Harman levels among smokers are 2-10 times higher than in non-smokers (1). It was reasoned that this reaction could be interfered by effective binding of carcinogenic acetaldehyde in the saliva (2) into a harmless compound using the Acetium-lozenge containing slowly releasing L-cysteine.
Compared to the placebo, the likelihood of smoking cessation among users of the test substance during the trial was up to 1.65-fold (i.e., 65 % higher probability). This figure favorably competes with those reported in large international studies for nicotine replacement therapy (NRT) (3). The results were promising enough to warrant a new, larger confirmatory study.
A cohort of 1,800 voluntary smokers will be invited to the new study, to be randomly allocated into two groups of equal size. The study design is otherwise similar to the previous intervention trial.
CEO Semi Korpela, Biohit Oyj: “The new study is implemented with the same study design and population sampling than the previous trial. We expect the new study to confirm the promising previous results. Unlike many commonly used current intervention methods, of which some medical treatment can cause severe side effects and nicotine products maintain the nicotine addiction, 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 used intervention method, the decision to quit smoking, however, has to be made in person. Despite the fact that the 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 smoking because of the smoking health hazards.’
Biohit Oyj Stock Exchange Release 4.11.2015 Acetium lozenge – a promising novel method to assist smoking cessation
Biohit Press Release 29.11.2013 Biohit Oyj to start a clinical intervention trial with Acetium® lozenge aimed at smoking cessation
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
Kuulas Helsinki in brief
Kuulas Helsinki is specialized in producing psychological insight into measurable and profitable business growth. We are a strategic partner for consumer understanding and we a have ten-year history in the industry. We work effortlessly in areas that require multivariate analysis as well as in-depth qualitative analysis methods. Kuulas Helsinki is a member of FAMRA. We follow the ESOMAR rules of good scientific practice. http://www.kuulas.fi/