ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
NicOx Initiates Two Large ABPM Studies For Naproxcinod In Hypertensive Patients With Osteoarthritis
NicOx S.A.
(Euronext Paris: COX) announced the initiation of two large clinical
pharmacology studies in the United States, which will assess the blood
pressure profile of naproxcinod in comparison to ibuprofen and naproxen,
using the Ambulatory Blood Pressure Monitoring (ABPM) technique. These
separate studies, 12 and 16 weeks in duration, will together recruit a
total of around 420 osteoarthritis patients with controlled hypertension
and results are projected in Q4 2008. Naproxcinod is NicOx' lead
investigational drug and the first compound in the COX-Inhibiting Nitric
Oxide-Donating (CINOD) class of anti-inflammatory agents, which is
currently in phase 3 clinical development for the treatment of the signs
and symptoms of osteoarthritis, with results of the last two phase 3
studies anticipated in the second half of 2008.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen and
naproxen, are commonly used by osteoarthritis patients to control their
chronic pain, inflammation and stiffness and significantly improve quality
of life for millions of people. However, these important products have the
tendency to raise blood pressure to an extent that may increase the rate of
serious cardiovascular adverse events (see NOTE 1).
Pascal Pfister MD, Chief Scientific Officer and Head of Research and
Development at NicOx, said: "Our development program for naproxcinod aims
to address the safety concerns surrounding anti-inflammatory agents and
blood pressure, which represents a serious medical issue. Previous studies
using the ABPM technique and Office Blood Pressure Measurements have
suggested that naproxcinod may have an improved blood pressure profile
compared to existing anti-inflammatory drugs, which would greatly
facilitate its future adoption by physicians and patients. These two new
studies will provide important data in a relevant population of chronically
treated osteoarthritis patients and should add additional weight to the
consistent data we are accumulating on naproxcinod's blood pressure
profile."
The objectives of these new ABPM studies (see NOTE 2) are to provide
important additional data on the 24-hour blood pressure profile of
naproxcinod in chronically treated osteoarthritis patients, in comparison
to commonly used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These data
should complement the promising results of a 2-week ABPM study for
naproxcinod in healthy volunteers with hypertension (the 104 study), which
were presented at the American Heart Association (AHA) in November 2007
(see press release of November 7, 2007). They will also complement the
Office Blood Pressure Measurements (OBPMs) being collected in each of the
pivotal phase 3 osteoarthritis studies (including the completed 301 study
and the ongoing 302 and 303 studies
Design of the 111 and 112 ABPM studies
-- The 111 study is a 12-week, phase 1, double-blind, parallel group,
exploratory trial, where approximately 120 patients will be enrolled
at around 30 clinical sites in the United States. Patients will have a
minimum age of 40 and be diagnosed with controlled essential
hypertension and osteoarthritis, with at least one hip or knee
involved. After a one week screening period, patients will be
randomized to one of two groups, which will receive increasing doses
of either naproxcinod or naproxen at three week intervals. 24-hour
blood pressure monitoring will be conducted at baseline and at the end
of each three-week dose escalation, using an ABPM device (see NOTE 2).
-- The 112 study is a 16-week, phase 1, double-blind, parallel group,
exploratory trial, where approximately 300 patients will be recruited
at around 60 clinical sites in the United States. As in the 111 study,
patients will be 40 years, or older, with osteoarthritis in at least
one hip or knee and a diagnosis of controlled essential hypertension.
Following a one week screening period, patients will be randomized to
either one of five groups, which will receive 13 weeks of treatment
with: naproxcinod 375 mg bid (twice-daily), naproxcinod 750 mg bid,
naproxen 250 mg bid, naproxen 500 mg bid or ibuprofen 600 mg tid. At
the end of the treatment period, all patients will receive placebo for
2 weeks. 24-hour blood pressure monitoring will be conducted at
baseline and at the end of the 13-week treatment period. The primary
objective of the study is to assess the mean change from baseline in
the average 24-hour systolic blood pressure, as well as evaluating the
general safety and tolerability of naproxcinod.
Staffan Stromberg, Vice President of Drug Development at NicOx, said:
"We have chosen naproxen as the comparator in the pivotal phase 3 studies,
due to its well established anti-inflammatory efficacy and its perception
as the least risky of the existing NSAIDs in terms of blood pressure and
cardiovascular safety. In the 112 study, we will also obtain long term
24-hour blood pressure comparisons between our first CINOD and ibuprofen,
the most widely used NSAID."
NOTE 1: The biological mechanisms by which NSAIDs increase blood
pressure are not well understood, although an increase in blood vessel
constriction, interference with antihypertensive treatment and retaining
dietary salt all seem to contribute. The extent of the increase is not
fully defined, although there appears to be a variation between different
products, with ibuprofen and the selective COX-2 inhibitors bringing about
greater increases than non- selective drugs, such as naproxen. However, all
existing products have been associated with some blood pressure increase.
Both treated hypertensive patients and individuals with normal blood
pressure appear to be affected and the dose and duration of administration
also seems to be important, with hypertension occurring more frequently
with chronic treatment.
NOTE 2: Ambulatory Blood Pressure Measurement (ABPM) involves using a
portable device to independently measure and record blood pressure at
frequent intervals over a 24-hour period with minimal disruption of a
subject's daily activity. In these new studies, blood pressure measurements
will be taken at 20-minute intervals between 6:00 am and 10:00 pm and every
hour from 10:01 pm to 5:59 am.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx
is applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas
of inflammatory and cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary
NCE and the first compound in the COX-Inhibiting Nitric Oxide-Donating
(CINOD) class of anti-inflammatory agents, which is in phase 3 clinical
studies for the treatment of the signs and symptoms of osteoarthritis, with
final phase 3 results anticipated in 2008.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric
oxide- donating NCEs, which are in development internally and with
partners, including Pfizer Inc and Merck & Co., Inc., for the treatment of
prevalent and underserved diseases, such as atherosclerosis, hypertension,
glaucoma and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext
Paris Stock Exchange (Compartment B: Mid Caps).
This press release contains certain forward-looking statements.
Although the Company believes its expectations are based on reasonable
assumptions, these forward-looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially
from those anticipated in the forward-looking statements.
For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of NicOx S.A. to
differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the Document de
Reference filed with the AMF, which is available on the AMF website
(http://www.amf-france.org) or on NicOx S.A.'s website
(http://www.nicox.com).
NicOx S.A.
http://www.nicox.com
NicOx iniþiazã douã mari studii pentru ABPM în Naproxcinod pacienþii hipertensivi cu osteoartrita - NicOx Initiates Two Large ABPM Studies For Naproxcinod In Hypertensive Patients With Osteoarthritis - articole medicale engleza - startsanatate