Biohit Oyj launches new methods and products for prevention of the
BIOHIT OYJ STOCK EXCHANGE RELEASE 22 MAY 2006 AT 2.00 PM
Biohit Oyj launches new methods and products for prevention of the
risk of gastrointestinal cancers
During recent years, powerful evidence has shown that acetaldehyde
acts as a local carcinogen in the human mouth, esophagus and
stomach. Acetaldehyde is dissolved from tobacco into the saliva,
and it is also produced from alcohol by microbes present in the
mouth. If the stomach contains very little or no acid because of
certain medications or due to mucosal damage caused by a
Helicobacter pylori infection, the microbes present in the stomach
may also produce alcohol from sugar and carbohydrates that is
further transformed into the carcinogenic acetaldehyde. Large
quantities of acetaldehyde are also found in many foodstuffs and
in smoke. These problems will undoubtedly attract more serious
attention in the future.
In order to prevent gastrointestinal cancers, Biohit Oyj has
developed and patented targeted methods and their associated
products in cooperation with Professors Mikko Salaspuro and Martti
Marvola as well as with Ville Salaspuro, who successfully defended
his Ph.D. thesis in Medicine on 28 April 2006.
As early as the 1990s, a research group led by Professor Mikko
Salaspuro published a hypothesis claiming that microbes in the
gastrointestinal tract locally produce acetaldehyde after alcohol
consumption and that the resulting locally formed acetaldehyde
exposes humans to cancers of the gastrointestinal tract. Smoking
and long-term use of large quantities of alcohol are known to
increase the risk of oral, pharyngeal and oesophageal cancers by
more than 20 times. Tobacco smoking significantly increases the
risk of stomach cancer, too. These epidemiological observations
may be at least partly explained by the fact that alcohol
consumption and smoking result in a strong local exposure to
acetaldehyde in the upper gastrointestinal tract, as shown by the
Ph.D. thesis publicly defended at the University of Helsinki on 28
April
(http://ethesis.helsinki.fi/julkaisut/laa/kliin/vk/salaspuro/).
The same study also shows that local exposure to acetaldehyde may
be reduced considerably by using cysteine-releasing tablets
developed by Finnish researchers and Biohits XyliCyst chewing gum
manufactured by Fennobon Oy. This chewing gum effectively
eliminates the acetaldehyde that builds up in saliva during
smoking. Researchers believe that oral cancers related to smoking
and alcohol consumption could be prevented in this way.
The carcinogenic acetaldehyde may also be built endogeneously by
microbes from certain foodstuffs such as sugar and carbohydrates,
especially in an anacidic stomach. Anacidity (achlorhydria) of the
stomach is a known risk factor for stomach cancer. People infected
with Helicobacter pylori almost half of the global population
may develop atrophic gastritis (atrophy and dysfunction of the
stomach mucosa) that often results in an anacidic stomach.
Even after a successful treatment of the Helicobacter infection
that caused the atrophic gastritis, atrophic stomach mucosa is
slow to heal and its function only improves slowly over several
years. For this reason, these patients, too, have anacidic
stomachs or their stomach does not contain enough acid to prevent
the growth of oral microbes in the stomach. Stomach acidity is
also reduced effectively by proton pump inhibitors (PPIs) used in
the treatment of gastroesophageal reflux disease, a disease
affecting approximately one quarter of the global population.
Stomach microbes that thrive in a mildly acidic or anacidic
stomach produce ethyl alcohol and acetaldehyde from food. A
BioCyst capsule taken with meals releases cysteine in the stomach
and thus inactivates the acetaldehyde, rendering it harmless.
Biohit Oyj has previously developed a laboratory test (the
GastroPanel examination, www.biohit.com/gastropanel) that among
other things is able to easily detect from a single blood sample
atrophic gastritis of the corpus of the stomach and the resulting
anacidic stomach. The goal now is to develop products that are
able to eliminate acetaldehyde effectively both in the stomach and
in other parts of the gastrointestinal tract. A need to use
stomach-related acetaldehyde-inactivating products (e.g. BioCyst
capsules containing cysteine) with meals may be shown safely and
economically by means of the GastroPanel examination.
BioCyst capsules and other related inventions
BioCyst capsules are believed to reduce the risk of acetaldehyde-
related gastric cancer in persons diagnosed by a GastroPanel
examination as having an anacidic stomach associated with atrophic
gastritis. The BioCyst capsules swallowed by these persons in
connection with meals release cysteine, which is thought to reduce
the risk of cancer caused by acetaldehyde absorbed from food or
produced by microbes of the mouth in an anacidic stomach. Slightly
less than one quarter of the global population have atrophic
gastritis; in Finland, the proportion is 8 to 12% depending on the
age group. This proportion will increase to substantially higher
levels as the population ages.
According to Biohits preliminary estimate, BioCyst will be
introduced to the market in 2007. The manufacture and marketing of
XyliCyst chewing gum is about to start. The chewing gum was
presented to approximately 350 cancer researchers at an
international conference on oral cancer at Grado, Italy on 14th to
17th May 2006
(http://www.icooc2006.nordestcongressi.it/general_info.php).
Biohit has also submitted a patent application on the use of
cysteine or similar compounds to inactivate the acetaldehyde
present in several foodstuffs. Biohit plans to make use of this
invention by licensing it for use by the food industry.
More information:
PRESS CONFERENCE AT HOTEL SCANDIC (Simonkatu 9, Helsinki) on 22
May 2006, starting at 2.00 p.m. (approximate duration: 1 hour).
Present: Professors Mikko Salaspuro, Martti Marvola and Osmo
Suovaniemi; Lic. Med. (PhD thesis successfully defended) Ville
Salaspuro; Chairman of the Board of Biohit Oyj, Professor Reijo
Luostarinen; and Helsinki University Press Officer Päivi M
Lehtinen.
Osmo Suovaniemi, M.D., Ph.D., Professor
President & CEO
Tel: +358-9-773 861
GSM: +358-40-745 5605
Email: osmo.suovaniemi@biohit.com
Distribution:
Helsinki Exchanges
Financial Supervisory Authority
Press
http://www.biohit.com
GastroPanel examination
The GastroPanel examination measures four biomarkers in blood:
Pepsinogen I and II, Gastrin-17 and Helicobacter pylori
antibodies. The GastroPanel examination
(www.biohit.com/gastropanel) and the GastroSoft software
(www.biohit.com/gastrosoft) interpreting its results have been
developed for use as a primary and follow-up examination in the
diagnosis and treatment of patients with dyspepsia, H. pylori
infection and atrophic gastritis. Pepsinogen I levels in blood and
the pepsinogen I to II ratio decrease in atrophic gastritis of the
corpus. Moreover, because of absence of acid secretion due to
corpus atrophy (atrophic gastritis), gastrin-17 levels are
strongly elevated. In most cases, atrophic gastritis is caused by
Helicobacter infection. It is more seldom that atrophic gastritis
of the corpus of the stomach and the consequent anacidic stomach
are due to an autoimmune disease.
If the GastroPanel examination gives a normal result, the
diagnosis is either functional dyspepsia or another disease not
involving the gastric mucosa. The examination diagnoses H. pylori
infection, atrophic gastritis and its location (corpus, antrum or
both). In addition to these diagnoses, GastroSoft software also
alerts to the risks associated with atrophic gastritis of the
corpus of the stomach (gastric cancer and vitamin B12 deficiency)
and to the risks associated with atrophic gastritis of the antrum
(gastric cancer and peptic ulcer disease). The GastroSoft report
also indicates the risk of gastroesophageal reflux disease and
vitamin B12 deficiency. If necessary, the report recommends
further examinations, such as gastroscopy and biopsy specimen
examination as well as vitamin B12 and homocysteine determinations
(see Table 1).
Should GastroPanel test show that the patient has atrophic
gastritis, risk of gastric cancer, for example, is increased and
it is necessary to carry out endoscopy and biopsy of the stomach
in order to detect gastric cancer and its preliminary stages
(found in about 2-5% of persons aged over 50 who have advanced
atrophic gastritis). GastroPanel is also suited for population
screening to identify and treat in time the patients with high
risk of gastric cancer. GastroPanel screening enables finding of
about 75% of gastric cancers at an early enough stage that total
cure is possible with surgical and endoscopic treatments. The
present treatment practice recommending screening of Helicobacter
infection with breath test and faecal antigen test (see Table 1),
this percentage is below 20%. On the basis of extensive study
material it is estimated that in Finland, GastroPanel screening of
population aged over 50 would enable preventing 250-300 deaths
from gastric cancer each year.
The Nobel Prize for medicine for the discovery of H. pylori and
its role in gastritis and peptic ulcer disease, made as early as
1982, was given to Australian doctors, Professors Barry J.
Marshall and J. Robin Warren in 2005. The GastroPanel invention
will allow practical medicine to benefit from the discovery of H.
pylori much more than before. When combined, these two inventions
promote the development of safe and ethical evidence-based
medicine.
__________________________________________
Table 1. Summary of the data provided by the GastroPanel
examination and the 13C- urea breath or stool antigen test of
the test-and-treat strategy to the doctor in charge. The
stochastic GastroSoft program supplies a patient report and in
consecutive examinations the graphs on the probabilities of
different conditions. The reports produced by GastroSoft are based
on clinical studies comparing the results of GastroPanel
examinations with results from gastroscopy and biopsy examinations
(www.biohit.com/gastrosoft ).
The serious medical and ethical problems of the test and treat
strategy can be corrected simply and economically by replacing its
13C- urea breath or stool antigen test by the GastroPanel
examination (www.biohit.com/gastropanel).
At an early stage
The 13C - urea
GastroSoft breath test or
report Stool antigen
states: test report:
the diagnosis for
Functional vs. organic dyspepsia. YES NO
When GastroPanel indicates the
gastric mucosa is healthy, the
dyspepsia complaints are often
caused by functional dyspepsia or
another disease not involving the
gastric mucosa
H. pylori infection (gastritis) YES NOT RELIABLE (1)
Atrophic gastritis (damaged and YES NO
severely dysfunctional gastric
mucosa) and the probabilities of
different conditions affecting the
mucosa of the gastric corpus or
antrum or both (normal, gastritis
or atrophic gastritis)
the risks (related to atrophic
gastritis) of
Gastric cancer YES YES/NO (2)
Vitamin B12 deficiency YES NO
Peptic ulcer disease YES YES/NO (3)
the risks of
Gastroesophageal reflux disease YES NO
and
Barretts esophagus YES NO
if necessary, a recommendation for
Gastroscopy and biopsy examination YES NO
Treatment of H. pylori infection YES YES/NO (4)
Determination of vitamin B12 and
homocysteine YES NO
Follow-up examination to monitor
the incidence of atrophic YES NO
gastritis
the healing of the H. pylori YES YES
infection
the healing of atrophic gastritis YES NO
(1)
The 13C- urea breath - and stool antigen tests give false negative
results if the patient has atrophic gastritis (a risk of gastric
cancer and peptic ulcer disease and vitamin B12 deficiency and
related diseases, such as dementia, depression and polyneuropathia
as well as atherosclerosis, strokes and heart attacks), MALT
lymphoma or bleeding peptic ulcer or if the patient is currently
receiving antibiotics or PPIs.
(2)
The risk of gastric cancer is very low without atrophic gastritis
in corpus, antrum or both. But in some cases, a H. pylori
infection without histologically observable atrophic gastritis may
be associated with gastric cancer and peptic ulcer disease.
(3)
No peptic ulcer disease with corpus atrophy (no acid, no ulcer).
The risk of peptic ulcer disease is very low without antrum
atrophy.
(4)
When the incidence of H. pylori -related atrophic gastritis is
monitored, the patient can be offered targeted, safe treatment at
the right time. The need for medication and the costs and adverse
effects of medication can thus be reduced. If the patient has been
diagnosed with peptic ulcer disease (gastric or duodenal ulcer),
the H. pylori infection has to be treated (5). It should also be
treated if the patient has atrophic gastritis. The patient and the
doctor may also agree on eradication treatment for other reasons
for example when the patients close relatives have been diagnosed
with gastric cancer.
(5)
Press Release: The 2005 Nobel Prize in Physiology or Medicine, 3
October 2005 jointly to Barry Marshall and J. Robin Warren for
their discovery of the bacterium Helicobacter pylori and its
role in gastritis and peptic ulcer disease: - An
indiscriminate use of antibiotics to eradicate Helicobacter pylori
also from healthy carriers would lead to severe problems with
bacterial resistance against these important drugs. Therefore,
treatment against Helicobacter pylori should be used restrictively
in patients without documented gastric or duodenal ulcer disease.
http://nobelprize.org/medicine/laureates/2005/press.html
In the USA GastroPanel is for research use only, not for in vitro
diagnostics.
