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M0002 Progresses To Phase IIb Trial Following Positive Results In Cirrhotic Ascites
Movetis NV, a European specialist pharmaceutical company, announced
that M0002 is progressing to phase IIb following positive results of a phase
IIa multiple-dosing trial for the treatment of ascites, the accumulation of
fluid in the abdomen in patients with liver cirrhosis resulting from liver
conditions such as hepatitis C, hepatitis B or alcoholism.
M0002 is an orally-active selective vasopressin 2 receptor
antagonist and a member of a new class of compounds, known as aquaretics,
which inhibit water reabsorption from the renal collecting duct. The compound
induces free water clearance without loss of sodium.
The randomized, double blind, placebo controlled, dose-titration study
explored the safety, tolerability, pharmacokinetic profile and efficacy of
M0002 in cirrhotic subjects with ascites and hypo- or normonatraemia. It was
conducted in Belgium at multiple centers and enrolled 15 patients who were
treated once daily with drug or placebo for 15 days.
"The data are encouraging," states Prof Dr. F. Nevens, Chief of
Hepatology at the University Hospital in Leuven and principal investigator of
the trial. "M0002 was very well tolerated and proved to have a good safety
profile. No unexpected side-effects were seen in these very ill patients. The
pharmacokinetic profile was in line with expectations."
Although a small number of patients were included in the
study, a trend towards more stabilized and normalized plasma sodium levels
was seen in those treated with M0002.
Remi Van den Broeck, Chief Development Officer of Movetis,
said, "We are delighted with the promising results from the dose-titration
trial. We will begin patient recruitment shortly for a Phase IIb dose-finding
study. At Movetis we are committed to improving the lives of patients with
ascites and we believe that M0002 may eventually offer hope to many who
suffer from the condition."
About cirrhotic ascites
Cirrhosis is a consequence of chronic liver disease, most
commonly caused by alcoholism and hepatitis B or C. It is characterized by
replacement of liver tissue by fibrous scar tissue as well as regenerative
nodules, leading to progressive loss of liver function. Ascites, the
accumulation of fluid in the peritoneal cavity, is a major complication of
cirrhosis. The development of ascites is a significant marker in the
progression of cirrhosis as it is associated with high mortality over two
years, and signifies the need to consider liver transplantation as a
therapeutic option.
Dr. F. Wong, Associate Professor of Medicine at Toronto
General Hospital, when asked for comment on the disease and on the
therapeutic options, said:
"The development of ascites, or fluid in the abdominal cavity,
is a common complication of liver cirrhosis. Its onset signifies the
progression of liver cirrhosis into the decompensated stage with worsening of
prognosis to 50% survival in 2 years. The treatment of ascites includes the
use of dietary sodium restriction, diuretics (loop diuretics and or
spironolactone) and large volume paracentesis. The continued use of diuretics
is limited by the development of complications such as electrolyte
abnormalities, and many patients eventually become diuretic resistant, that
is, the use of diuretics is no longer resulting in a reduction of ascites.
Such patients are totally dependent on large volume paracentesis as a means
of controlling the ascites. The use of paracentesis is inconvenient to the
patient and requires significant medical manpower."
Both Prof. Wong and Prof. Nevens agree that there is an urgent
need for newer and effective drugs to better manage cirrhotic patients with
ascites.
About M0002
M0002 is a selective vasopressin 2 receptor antagonist and is
a member of a new class of compounds - aquaretics - that produce significant
diuresis without the loss of electrolytes. Conventional diuretic drugs, which
are currently used to treat ascites, have the drawback that they promote the
excretion of both salt and water, leading to possibly symptomatic
hyponatremia (abnormally low concentration of sodium in the blood). In
contrast, M0002 primarily increases free water clearance. This important
differentiation could potentially offer clinical advantages in the treatment
of cirrhosis and other disorders caused by water-retention.
About Movetis
Through a clear focus on gastroenterology (GI), Movetis seeks
to improve the lives of millions of patients - both adults and children - by
discovering, developing and ultimately commercialising innovative treatments
targeting GI conditions with a high unmet medical need. Movetis NV - founded
in Belgium in December 2006 - aims to become a leading European specialty
pharmaceutical organisation focused on GI diseases. Movetis has a broad GI
portfolio with one product in preregistration, two products in clinical
development, one product ready to move into clinical development and four in
preclinical development, all addressing important areas including chronic
constipation, ascites, paediatric reflux in infants, diabetic gastroparesis,
specific subgroups of patients with severe forms of irritable bowel syndrom
or dyspepsia. In addition, Movetis has rights to a large library of qualified
lead compounds with potential for development in different GI indications and
access to know how for compounds in secretory diarrhoea. The current
portfolio has been licensed from Janssen Pharmaceutica NV, Belgium and
Ortho-McNeil Pharmaceutical Inc., two Johnson & Johnson (J&J) companies.
http://www.movetis.com
M0002 progreseazã la faza IIb Trial urma rezultate pozitive în Cirrhotic ascitã - M0002 Progresses To Phase IIb Trial Following Positive Results In Cirrhotic Ascites - articole medicale engleza - startsanatate