Biohit has been granted a U.S. patent for an invention of binding carcinogenic acetaldehyde in gastrointestinal tract and in nutrition

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Helsinki Stock Exchange, 2012-10-16 17:00 CEST (GLOBE NEWSWIRE) -- Biohit Oyj, Stock exchange Release 16th October 2012, at 18:00 EET 

Biohit Oyj has been awarded US patent 8,227,513 B2, which is valid until 3.4.2026.

The object of this BioFood-invention comprises food compositions, to which one or more acetaldehyde-binding compositions are added. The purpose of the compositions is to reduce the amount of detrimental acetaldehyde in the area of the mouth, the pharynx, the esophagus, the stomach, and the small and large intestines, and through this, to reduce the risk of developing cancers in these areas.

Group I human carcinogens such as acetaldehyde, asbestos, benzene and formaldehyde, regardless of the source, are bound to the uniform international principle. Exposure to them should be avoided by all means.  Exposure to acetaldehyde has been shown to be one of the most significant factors causing cancer in the upper gastrointestinal tract (mouth, the pharynx, the esophagus, the stomach). Nearly one and half a million people worldwide die for those cancers every year, thus they are the main cause of cancer–related death. In addition, these cancers have exceptional poor prognosis, and hence it is extremely important to prevent and diagnose them in the early phase.   

Biofood method invented by Biohit Oyj is intended to reduce the food stuff mediated exposure to acetaldehyde. In addition, Biohit´s GastroPanel diagnosis method is developed to identify major risk groups for esophageal and gastric cancer, for whom the avoidance of acetaldehyde is of particular importance.  

 

 

 

Biohit Oyj

Semi Korpela, toimitusjohtaja

Tel. +358 9 773 86 333

semi.korpela@biohit.fi

 

 

 

 

 

 

 

 

 

 

Additional Information

It would be desirable that, for example, the dairy products (including yogurt) and baby food as well as alcoholic and soft drinks product packages should include information of acetaldehyde concentration. This would increase the knowledge of acetaldehyde concentration and give the possibility for consumers to choose the products that have little or no carcinogenic acetaldehyde.

Biohit's service laboratory offers alcohol and acetaldehyde concentrations determination services for nutrients in foods and alcoholic beverages. This service is suitable for food industry, research institutions and supervisory authorities as well as consumers (www.biohit.fi/ Laboratory, www.acetium / test reveals acetaldehyde.

Acetium developed by Biohit has been granted a patent protection in Europe. This means that Acetium product is protected with an extensive patent protection in Europe (www.biohithealthcare.com: Investors/ Stock Exchange Releases: 20/07/2012: European Patent Awarded to Biohit Oyj’s Acetium). Patents are also pending outside Europe.

The L-cysteine in Acetium capsules dissolves slowly into the gastric fluid, efficiently binding (neutralising) carcinogenic acetaldehyde in an achlorhydric stomach. This contributes to the prevention of stomach and oesophageal cancer. Such cancers are typically diagnosed late, which results in a particularly poor prognosis.

The science behind the Acetium innovation is strong and there is a great need for this product. Identifying the specific carcinogenic substance is crucial to preventing a particular cancer. Insufficient ability to remove acetaldehyde caused by point mutation provides a human model for acetaldehyde exposure, helping to explain the high incidence rates of upper gastrointestinal tract cancers in alcohol drinkers. The consistent epidemiological and biochemical results obtained from this model prompted the World Health Organization’s International Agency for Research on Cancer (IARC) in October 2009 to classify the acetaldehyde found in, and generated endogenously from, alcoholic beverages as a Group I carcinogen, i.e. as carcinogenic as asbestos, formaldehyde and benzene. One principle applies to all Group I carcinogens: every available means should be used to reduce exposure to these substances. Exposure to acetaldehyde is linked to more than three million new gastrointestinal cancers per year globally, which represents approximately 25 per cent of all cancers (visit www.acetium.com to test your exposure to acetaldehyde).

The Acetium capsule is the only product in the world proven to reduce exposure to acetaldehyde. Acetium is intended e.g. for persons suffering from an achlorhydric stomach caused by atrophy of the gastric mucosa and functional disorder (atrophic gastritis). An anacidic stomach is the most significant risk factor in stomach and oesophageal cancer. The risk group includes approximately 500 million people globally. An achlorhydric stomach caused by atrophic gastritis can be easily diagnosed from blood samples, using the GastroPanel biomarker test developed by Biohit Oyj.

The Acetium and GastroPanel innovations provide new opportunities for safe and cost-effective health care, as well as opportunities to tap into large and growing markets in cooperation with other Finnish and international companies and researchers (see Additional information and www.biohithealthcare.com: ”State-of-the-art GastroPanel and Acetium innovations for the unmet need” and ”GastroPanel biomarkers).

Acetium capsules, which are available in pharmacies without prescription, are recommended to those with

1 the long-term need to use medications that reduce gastric acid (HCl) secretion (PPI medication and H2 blockers); approximately 5-10% of Western population use these occasionally or regularly, and possibly more than 500,000 people in Finland,

2. an achlorhydric or low-acid stomach caused by atrophic gastritis resulting from Helicobacter pylori infection or an autoimmune disease, which can be diagnosed with GastroPanel (500 million worldwide)

3. an untreated chronic Helicobacter pylori infection, which can be reliably diagnosed with GastroPanel (more than 500 million people worldwide),

4. people who have undergone stomach surgery (over a million people worldwide),

5. people with gene mutation affecting acetaldehyde metabolism: 30–50% of Asians show ALDH2 deficiency.

Although data on the effectiveness of Acetium in the prevention of gastric and oesophageal cancer is not yet available, there is conclusive scientific evidence to suggest that acetaldehyde, a group I carcinogen, causes cancer, and that acetaldehyde is generated in an achlorhydric stomach, which is a known risk factor for gastric and oesophageal cancer. Exposure to acetaldehyde is linked to more than three million new gastrointestinal cancers per year globally, which represents approximately 25 per cent of all cancers.

Acetium and GastroPanel innovations support each other. GastroPanel biomarkers find atrophic gastritis in corpus, which leads towards anacidic stomach. The anacidic condition in stomach will most likely not heal and can stay forever. Like above it is mentioned, cancer risk linked to anacidic stomach can be reduced by eating Acetium capsules while eating and drinking.   

Unlike the Helicobacter pylori examinations still being used (13C urea breath test and stool antigen test), the GastroPanel biomarker test reliably detects H. pylori infection,the typically asymptomatic condition atrophic gastritis, and associated risks, including cancer.

As much as 20-40% of the Western population suffers from dyspepsia, which, according to conventional medical practice, requires gastroscopy. There are no resources available, nor is there any need for such examinations or high-risk experimental medications. The GastroPanel biomarker test allows only ill and at-risk patients to be referred for gastroscopy and treatment. This increases patient safety, and saves 40-70% of scarce and expensive endoscopy capacity to be used for colonoscopies for early diagnosis and prevention of colorectal cancer. Particularly with elderly people, problems in the colon are often the cause of dyspepsia complaints. It is therefore advisable to supplement GastroPanel with a ColonView test to select at-risk patients for colonoscopy (www.biohithealthcare.com: Diagnostics / Product brochures).

The April 2012 Maastricht IV consensus report of the European Helicobacter Pylori Study Group recommends blood sample biomarker tests as a reliable method of diagnosis of diseases of the stomach mucosa and associated risk conditions.

Researchers recommend biomarker tests for the diagnosis and follow-up of Helicobacter pylori infection and especially for atrophic gastritis that causes achlorhydric stomachs, in addition to recommending the screening of asymptomatic patients (www.biohit.fi: Investors/ Stock Exchange Releases: 08/06/2012).

The international Healthy Stomach Initiative group’s 16 gastroenterology experts from 12 countries (www.hsinitiative.org) came to the same conclusions. Biomarker tests can be used to diagnose and screen atrophic gastritis and related risks in both asymptomatic patients and patients with abdominal discomfort (www.biohithealthcare.com: Investors/ Stock Exchange Releases: 17/02/2012 Biohit Oyj’s GastroPanel biomarker test recommended).

The state-of-the-art, highly informative, safe and cost-effective GastroPanel biomarker test for diagnosing dyspepsia (various upper abdominal complaints) and Helicobacter pylori infection does not involve any of the problems described below.

•The 13C urea breath test (UBT), stool antigen test and antibody tests alone do not detect atrophic gastritis of the corpus caused by H. pylori infection or autoimmune disease, or atrophic gastritis of the antrum caused by H. pylori infection. Atrophic gastritis is almost always asymptomatic and usually incurable.

• Undiagnosed atrophic gastritis of the corpus (achlorhydric stomach) may cause gastric and oesophageal cancer and malabsorption of vitamin B12, iron, magnesium, calcium and certain drugs.

• Calcium deficiency causes osteoporosis. Vitamin B12 deficiency can cause pernicious anaemia, dementia, depression and damage to the peripheral nervous system.

• The absorption of several drugs such as dipyridamole, some iron products and antifungals (fluconazole, itraconazole), thyroxine and atazanavir is considerably impaired in an achlorhydric stomach. Particularly in senior citizens, the risk of severe intestinal infections (such as giardiasis, malaria, Clostridium difficile and E. coli EHEC) increases.

• Atrophic gastritis in the gastric antrum increases the risk of peptic ulcer disease and gastric cancer. If both the antrum and corpus mucosa are atrophic, this condition poses the highest risk for gastric cancer known to date. In some cases, gastric cancer is directly caused by H. pylori and gastritis. Less than 1% of the population has hereditary gastric cancer.

• Furthermore, none of the aforementioned three H. pylori tests provide any information on excessive gastric acid secretion, which in patients with gastro-oesophageal reflux disease may cause complications from this disease. Such complications are often asymptomatic and include ulcerative oesophagitis and Barrett’s oesophagus, which may lead to oesophageal cancer if left untreated. If complications of the gastroesophageal reflux disease are suspected due to excessive acid secretion, or if the patient has atrophic gastritis or symptomatic Helicobacter pylori infection, gastroscopy is required to rule out cancer and other risks.

• In addition, the 13C urea breath test and stool antigen test may give up to 40% false negative results: in other words, the infection including cancer and other risks may be left undiagnosed if the patient has atrophic gastritis, MALT lymphoma or bleeding peptic ulcer disease, or if the patient is currently receiving antibiotics or PPI treatment.

In order to prevent medical malpractice, unnecessary costs and even unnecessary deaths caused by cancer, the current Helicobacter pylori tests should be replaced by the GastroPanel biomarker examination. With the GastroPanel tests readily available, treating patients suffering from stomach discomfort without further diagnosis can no longer be justified. Risky self-treatment of stomach discomforts may delay the diagnosis of, for example, precancerous gastric lesions until the disease has progressed beyond treatment. Approximately one-third of the population in Finland suffer from stomach discomfort. Tens of thousands of patients from this group receive proton pump inhibitor (PPI) treatment or take prescription-free PPI medication, regardless of the fact that they already have an achlorhydric stomach caused by atrophic gastritis and the associated risks of cancer and other diseases.

Proton pump inhibitor (PPI) medications, both prescribed and those available without prescription, come with the following warning: ”If the patient has alarming symptoms (e.g. significant unintentional weight loss, persistent continuous vomiting, difficulty swallowing, blood in vomit or in stool) and a suspected or diagnosed peptic ulcer, any malignant conditions must be ruled out because PPI treatment can alleviate the symptoms and delay diagnosis.” This warning is justified but insufficient to lower the extremely high mortality rate in patients with stomach and oesophageal cancer. When “alarming symptoms” have appeared, the cancer has usually advanced to a non-curable stage. Despite this warning and without ruling out atrophic gastritis (achlorhydric stomach), stomach discomfort is very often treated with PPI and other medications that reduce gastric acid (HCl). Furthermore, atrophic gastritis and the associated cancer risk caused by both a Helicobacter pylori infection and an autoimmune disease typically cause few or no symptoms.

Osteoporosis and vitamin B12 deficiency represent a major public health problem among the elderly, and may typically be caused by asymptomatic undiagnosed atrophic gastritis. A person with an autoimmune atrophic gastritis of the corpus may simultaneously suffer from an another autoimmune disease, such as thyroiditis, celiac disease, rheumatoid arthritis and type 1 diabetes; or vice versa, a person with thyroiditis and type 1 diabetes often suffers from autoimmune asymptomatic atrophic gastritis and the resulting risk of gastric and oesophageal cancer as well as vitamin B12 deficiency. GastroPanel helps to detect at-risk patients in time and refer them to gastroscopy and treatment.

 

Literature on Acetium and acetaldehyde

1. Salaspuro V, Hietala J, Kaihovaara P, Pihlajarinne H, Marvola M, Salaspuro M. Removal of acetaldehyde from saliva by a slow-release buccal tablet of L-cysteine. Int J Cancer 2002; 97:361-4.

3. Salaspuro VJ, Hietala JM, Marvola ML, Salaspuro MP. Eliminating carcinogenic acetaldehyde by cysteine from saliva during smoking. Cancer Epid Biomark Prev 2006; 15:146-9.

4. Kartal A, Hietala J, Laakso I, Kaihovaara P, Salaspuro V, Sakkinen M, et al. Formulation and in vivo evaluation of L-cysteine chewing gums for binding carcinogenic acetaldehyde in the saliva during smoking. J Pharm Pharmacol. 2007;59:1353-8.

5. Linderborg K, Marvola T, Marvola M, Salaspuro M, Färkkilä M, Väkeväinen S. Reducing carcinogenic acetaldehyde exposure in the achlorhydric stomach with cysteine. Alcoholicm Clin Exp Res, 2011;35:1-7.

 

Literature on GastroPanel

 

1.Malfertheiner et al. Management of Helicobacter pylori infection. The Maastricht IV/ Florence Consensus Report. gut-bmj.com on May 18, 2012. European Helicobacter Pylori Study Group, ESPSG  2.Agreus et al. Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers, Scandinavian Journal of Gastroenterology 2012; 47: 136 – 147)  3.WHO. http://www.iarc.fr/en/media-centre/pr/2009/pdfs/pr196_E.pdf