LYSAKER, NORWAY, Jun 02 (MARKET WIRE) —
This information is subject of the disclosure requirements acc. to
Section 5- 12 vphl (Norwegian Securities Trading Act)
02.June 2010, Lysaker – Today it was agreed that NattoPharma’s natural
vitamin K2, MenaQ7(R), will be used in the VitaVasK study, a placebo-
controlled, double-blind multinational European randomized trial. The
hypothesis that the dietary supplementation of MenaQ7(R) 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(R) in some
600 kidney patients over one and a half years. VitaVasK is being financed
by a EUR1,8mill 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 Juergen
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(R) 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(R) 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(R) 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(R) 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(R)
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(R) as a drug in the future” says Morten Sundsto, CEO
of
NattoPharma.
For further information:
Morten Sundsto
CEO NattoPharma ASA
Phone: +47 950 61860
[HUG#1421003]
NattoPharma – First Step Into The Pharmaceutical
Market: http://hugin.info/137386/R/1421003/370437.pdf
Copyright 2010, Market Wire, All rights reserved.