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An Important Patent Granted To Biohit Acetium Capsule In Japan



9/11/2017 11:16:10 AM

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Biohit Oyj press release 11 September 2017 at 10:30 am. Local time (EEST)

Biohit Acetium® Capsule was granted in July 21, 2017 an important patent in Japan, valid until May 22, 2027 (Patent No: 6178657). The Patent is entitled: “Composition and method for binding acetaldehyde in stomach.” and it covers comprehensively all the fields of application of the Biohit Acetium® Capsule, as well as its eventual future modifications in composition, dosage and indications for use.

This patented invention relates to a non-toxic composition which bind carcinogenic acetaldehyde present in the stomach, intestine and/or colon. The composition comprises one or more acetaldehyde-binding compound(s) comprising one or more free sulphhydryl and/or amino groups. The compound(s) are mixed with a non-toxic carrier that effects sustained release of said compound(s) in the gastrointestinal tract. These compositions are of benefit in particular to patients having atrophic gastritis or achlorhydric or low-acid stomach. 

Acetium® Capsule was originally designed to complement the range of Biohit’s diagnostic tests, most notably the GastroPanel® innovation (www.biohithealthcare.com/additional-information). This panel of four biomarkers:  pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and HP-antibodies is used for diagnosis of dyspeptic symptoms and for screening of asymptomatic subjects to disclose the risks of gastric cancer, i.e., Helicobacter pylori (HP) infection and atrophic gastritis (AG) (1). Severe AG leads to acid-free stomach, colonized by HP and other bacteria, producing acetaldehyde, classified as Group I human carcinogen by IARC in 2009 (2). Together with other conditions leading to a) acid-free stomach (e.g. long-term users of PPI medication, autoimmune AG) or b) those exposing the subjects to increased concentrations of acetaldehyde (e.g. cigarette smokers, alcohol intake, ALDH2 enzyme mutations), these subjects are at high-risk for gastric and esophageal cancer (1-3).

Acetium® Capsule is a novel formulation of slow-release L-cysteine, being a unique medical device designed for elimination of carcinogenic acetaldehyde in the stomach (4). A regular use of Acetium® Capsule is indicated for all those who have acid-free stomach (ca. 700 million), irrespective of its cause, for preventing the possible risk of gastric and esophageal cancer. The most common high-risk groups include the following: 1) AG associated with HP infection; 2) AG caused by autoimmune mechanisms; 3)  cigarette smokers; 4) alcohol consumers; 5) long-term users of PPI (proton-pump inhibitor) medication, and 6) those (around 500 million) people in Asia who have a mutation of the aldehyde dehydrogenase (ALDH2) enzyme, failing to metabolize acetaldehyde to acetic acid, and exposed to higher local concentrations of acetaldehyde (4).

Chief Medical Director, Prof. Kari Syrjänen, Biohit Oyj: “The efficacy of Acetium® Capsule in acetaldehyde elimination has been documented in several controlled clinical experiments (4-6). In these studies, slow-release L-cysteine effectively (by 60–80%) eliminates carcinogenic acetaldehyde in patients with acid-free stomach caused by either AG or PPI treatment. This was the case in individuals with either active or deficient ALDH2 enzyme. L-cysteine capsules eliminate carcinogenic acetaldehyde locally in the stomach by forming a stable 2-methylthiazolidine carboxylic acid (MTCA). This capacity of slow-release L-cysteine to eliminate acetaldehyde persisted for up to three hours after ingestion of two Acetium® Capsules. 

CEO Semi Korpela, Biohit Oyj: “In Japan, gastric cancer has ranked as the most common cancer by both incidence and mortality for the last several decades. Recently, the prevalence of HP-infection has dramatically declined by birth cohort effect, mainly due to improvements in the general environmental hygiene in childhood (7). Older generations born before 1950 still show a high HP prevalence of around 80-90%. This major change will pose challenges in the strategies of both primary and secondary prevention of gastric cancer. The risk-stratified approach to gastric cancer prevention should be considered in Japan and other countries which have similarly experienced rapid economic development (7). With a rational combined use of GastroPanel®  (diagnosis) and Acetium® Capsule (prevention), one can diagnose the gastric cancer risks groups and subsequently protect their stomach against carcinogenic acetaldehyde exposure.”

References:

1.Syrjänen K. A Panel of serum biomarkers (GastroPanel®) in non-invasive diagnosis of atrophic gastritis. Systematic review and meta-analysis. Anticancer Res 2016;36,5133-5144.

2.Secretan B, Straif K, Baan R, Grosse Y, El Ghissassi F, Bouvard V, Benbrahim-Tallaa L, Guha N, Freeman C, Galichet L, Cogliano V. WHO International Agency for Research on Cancer Monograph Working Group. A review of human carcinogens - Part E: tobacco, areca nut, alcohol, coal smoke, and salted fish. Lancet Oncol 2009;10:1033-1034.

3.Tu H, Sun L, Dong X, Gong Y, Xu Q, Jing J, Bostick RM, Wu X, Yuan Y.A Serological biopsy using five stomach-specific circulating biomarkers for gastric cancer risk assessment: A multi-phase study. Am J Gastroenterol. 2017;112:704-715.

4.Linderborg K, Marvola T, Marvola M, Salaspuro M, Färkkilä M, Väkeväinen S. Reducing carcinogenic acetaldehyde exposure in the achlorhydric stomach with cysteine. Alcohol  Clin  Exp  Res 2011;35:516–522.

5.Maejima R, Iijima K, Kaihovaara P, Hatta W, Koike T, Imatani A, Shimosegawa T, Salaspuro M. Effects of ALDH2 genotype, PPI treatment and L-cysteine on carcinogenic acetaldehyde in gastric juice and saliva after intra-gastric alcohol administration. PLoS One. 2015;10:e0120397.

6.Hellström PM, Hendolin P, Kaihovaara P, Kronberg L, Meierjohann A, Millerhov A, Paloheimo L, Sundelin H, Syrjänen K, Webb D-L, Salaspuro M. Slow-release L-cysteine capsule prevents gastric mucosa exposure to carcinogenic acetaldehyde: results of a randomised single-blinded, cross-over study of Helicobacter-associated atrophic gastritis. Scand. J. Gastroenterol 2016;52:230-237.

7.Inoue M. Changing epidemiology of Helicobacter pylori in Japan. Gastric Cancer. 2017;20(Suppl 1):3-7.

Additional information:
Chief Medical Director, professor Kari Syrjänen, Biohit Oyj kari.syrjanen@biohit.fi or
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 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 Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com


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