NattoPharma - First Step Into The Pharmaceutical Market
(Thomson Reuters ONE) -
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
02.June 2010, Lysaker - Today it was agreed that NattoPharma's natural vitamin
K2, MenaQ7(®), will be used in the VitaVasK study, a placebo-controlled,
double-blind multinational European randomized trial. The hypothesis that the
dietary supplementation of MenaQ7(®) can delay the progression of vascular and
valvular calcification in patients on chronic hemodialysis will be tested. The
study will last for three years and will measure placebo controlled the effect
of high doses of MenaQ7(®) in some 600 kidney patients over one and a half
years. VitaVasK is being financed by a ?1,8mill grant from the European Renal
Association.
Patients on hemodialysis (HD) exhibit an enormous increase in cardiovascular
mortality associated with extensive vascular calcification (VC). Matrix Gla
protein (MGP) is a powerful inhibitor of VC. MGP is produced by vascular smooth
muscle cells and is activated (carboxylated) by vitamin K. "The proposed
VitaVasK study will be the first clinical trial in HD patients to target the
progression of VC using dietary vitamin K-mediated supplements", says principle
investigator Prof Jürgen Floege, head of the nephrology department at the
University Hospital of the RWTH Aachen University, in Germany.
Studies carried out at Maastricht University, in collaboration with NattoPharma,
indicate that MenaQ7(®) has the potential to prevent or even reduce vascular
calcification. Especially in patients prone to vascular calcification, such as
those with chronic kidney disease, this calcification reduction may positively
influence patient outcome. In a pilot study, it was shown that hemodialysis
patients revealed an extreme vitamin K deficiency and inactive MGP, indicating
that they do not have the ability to protect against arterial calcification. It
was shown that six weeks of MenaQ7(®) supplementation increased the active MGP
levels in these patients in a dose-dependent manner, suggesting that disturbed
calcification inhibitory activity in the vasculature may be improved by
MenaQ7(®) supplementation, hopefully leading to a better outcome for dialysis
patients.
According to one of the principle investigators of the Vitamin K2 study in
dialysis patients, Dr Leon Schurgers, senior scientist at Maastricht University
and VP of R&D at NattoPharma, "Calcification of the arteries seen in chronic
kidney disease is the same type of calcification which is found in aging
populations. The accumulation of calcium salts in the arteries results in
stiffening and increased fragility. This might be considered a 'silent killer'
as hardening of the arteries develops without any symptoms over time." Further,
he stated that current evidence now indicates that "the process of calcification
is an actively regulated process and that adequate MenaQ7(®) intake can prevent
this process and eliminate this risk factor."
Prof Peter Stenvinkel, nephrologist at the Karolinska institute explains,
"Whereas 500.000 people in Europe and the USA suffer from dialysis-dependent
chronic kidney disease, signs of mild to moderate CKD (Chronic Kidney Disease)
are found in more than 10 million patients. Compared to the general population,
patients with advanced chronic kidney disease experience a 10 - 100x increased
risk of cardiovascular complications, which translates into a mortality risk
comparable to the one found in patients with mestastatic cancer disease. This
problematic situation is further complicated by the fact that many treatment
strategies (including statins, increased dialysis dose and erythropoietin), in
randomized controlled trials have not been shown to improve survival in this
patient group. A major problem in dialysis patients is accelerated vascular
calcification; a process that increases the risk of cardiovascular complications
and premature death. As this deleterious process may be accelerated by a
subclinical deficiency of vitamin K2, MenaQ7(®) supplementation may be a novel
beneficial treatment strategy to slow down the calcification process and lower
the risk of cardiovascular complications without troublesome side effects in
this unfortunate patient group."
"We see this as our first step into the pharmaceutical market. Until now, we
have only done trials in healthy subjects. Now, for the first time, we are part
of a large trial in dialysis patients suffering from a disease with a high
mortality. Thus, if this trial is successful, we see a great potential for
MenaQ7(®) as a drug in the future" says Morten Sundstø, CEO of NattoPharma.
For further information:
Morten Sundstø
CEO NattoPharma ASA
Phone: +47 950 61860
[HUG#1421003]
NattoPharma ? First Step Into The Pharmaceutical Market: http://hugin.info/137386/R/1421003/370437.pdf
Unternehmensinformation / Kurzprofil:
Datum: 02.06.2010 - 11:02 Uhr
Sprache: Deutsch
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