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VIA Pharmaceuticals Enrolls First Patient In Phase 2 Clinical Trial To Measure Impact Of VIA-2291 To Reduce Vascular Inflammation
VIA Pharmaceuticals
(Nasdaq: VIAP), a biotechnology company focused on the development of
compounds for the treatment of cardiovascular disease, announced that
it has enrolled the first patient in its Phase 2 clinical trial that
utilizes Positron Emission Tomography with fluorodeoxyglucose tracer
(FDG-PET) to measure VIA-2291's ability to reduce vascular inflammation in
treated patients. The company also provided a comprehensive update of its
VIA-2291 Phase 2 clinical program.
VIA-2291 is a potent small molecule drug that targets inflammation in
the blood vessel wall, a primary disease process in atherosclerosis. It is
being developed as a once-daily, oral drug to potentially decrease the risk
of major adverse cardiovascular events associated with inflammation,
including heart attack and stroke. The FDG-PET trial is one of three
concurrent, ongoing Phase 2 trials testing VIA-2291 in a variety of
clinical settings. The Phase 2 clinical program's innovative trial designs
are intended to provide new visibility to the role of inflammation in
cardiovascular disease and the potential of VIA-2291 to address vascular
inflammation.
"The continued momentum in our Phase 2 clinical program and the
robustness of the trial designs put us on track to deliver critical
proof-of-concept data for VIA-2291 later this year," said Lawrence K.
Cohen, PhD, chief executive officer of VIA Pharmaceuticals. "Inflammation
is the root cause of cardiovascular disease and there remains a significant
unmet need to address the major adverse events, including heart attack and
stroke, associated with this disease. Despite currently available
medications that treat the conditions that increase the risk of these
events, these therapies do not treat the underlying inflammation."
The company provided the following specific update for each of its
three Phase 2 clinical trials:
FDG-PET Study
The FDG-PET trial is enrolling approximately 50 patients following a
heart attack into a 24 week randomized, double blind, placebo-controlled
study. Enrollment is expected to be complete during 2008 and data is
expected in the first half of 2009. Endpoints in the study include
reduction in plaque inflammation following dosing with VIA-2291 as measured
with FDG-PET, as well as assessment of standard biomarker measurements of
inflammation. The use of state-of-the art FDG-PET imaging technology
provides a new and important methodology for measuring the effect of
VIA-2291 in reducing vascular inflammation.
"We are pleased with the progress of our clinical program and the
commencement of our third Phase 2 trial to directly demonstrate the impact
of VIA-2291 on inflammation in patients with advanced atherosclerotic
disease," said Adeoye Olukotun, MD, chief medical officer of VIA. "The data
from this study, in combination with our other two trials, is designed to
directly assess the safety, mode of action and clinical activity of
VIA-2291 to reduce vascular inflammation, and therefore, the risk of major
adverse cardiovascular events."
The first patient was randomized to treatment at Massachusetts General
Hospital in Boston. Mount Sinai Heart in New York City is also
participating in the study.
Carotid Endarterectomy (CEA) Study
VIA has enrolled approximately 40 patients in the CEA study as planned,
and is expanding enrollment to gather additional data by taking advantage
of additional patients currently in the screening and patient recruitment
process. VIA plans to enroll approximately 50 patients and expects to
report data in the third quarter of 2008 from this study.
The CEA study is designed to evaluate the efficacy of VIA-2291 in the
vessel wall, and has the unique advantage of providing access to
atherosclerotic tissue for direct evaluation of VIA-2291's effect on
inflammation, through a panel of assays and histological examinations.
Acute Coronary Syndrome (ACS) Study
The ACS study has enrolled more than two-thirds of the targeted 200
patients for this trial and top-line data results are anticipated to be
released shortly after the release of data from the CEA trial. This study
is designed to establish dose and safety data in patients with acute
coronary syndrome (ACS) who have experienced a recent heart attack, and
includes measures of leukotrienes, biomarkers of inflammation as well as
medical imaging of the coronary vessel wall to evaluate impact on plaque
characteristics.
About VIA-2291
VIA-2291 is a selective and reversible inhibitor of 5-LO, which is a
key enzyme in the biosynthesis of leukotrienes (important mediators of
inflammation involved in the development and progression of
atherosclerosis). Potentially a complement to current standard of care
therapies that treat risk factors, such as statins, antiplatelet and blood
pressure medications, VIA-2291 is initially targeted to address the
secondary prevention market for patients who have already suffered a major
adverse cardiovascular event, but eventually could be beneficial to the
broader 15.8 million patients in the U.S. who have coronary artery disease.
VIA has exclusive worldwide rights to develop and commercialize VIA-2291.
Based upon prior trials of VIA-2291 in more than 1,100 patients, VIA
believes that VIA-2291 will be safe and well tolerated in doses currently
being administered in the ongoing clinical trials.
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the
development of compounds for the treatment of cardiovascular disease. VIA
is building a pipeline of small-molecule drugs that target a significant
unmet medical need: reducing inflammation in the blood vessel wall, which
is an underlying cause of atherosclerosis and its complications, including
heart attack and stroke. The company's lead drug candidate, VIA-2291, is in
multiple Phase 2 clinical studies in patients with cardiovascular disease.
For more information, visit: http://www.viapharmaceuticals.com.
Forward-Looking Statements
This press release may contain "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements relate to future events or to VIA's future financial performance
and involve known and unknown risks, uncertainties and other factors that
may cause VIA's actual results, levels of activity, performance or
achievements to be materially different from any future results, levels of
activity, performance or achievements expressed or implied by these
forward-looking statements. In some cases, you can identify forward-looking
statements by the use of words such as "may," "could," "expect," "intend,"
"plan," "seek," "anticipate," "believe," "estimate," "predict,"
"potential," "continue" or the negative of these terms or other comparable
terminology. You should not place undue reliance on forward-looking
statements since they involve known and unknown risks, uncertainties and
other factors which are, in some cases, beyond VIA's control and which
could materially affect actual results, levels of activity, performance or
achievements.
Factors that may cause actual results to differ materially from current
expectations include, but are not limited to:
-- our ability to obtain necessary financing;
-- our ability to control our operating expenses;
-- our ability to recruit and enroll patients for the CEA, ACS and
FDG-PET clinical trials;
-- our ability to successfully complete our clinical trials of VIA-2291
on expected timetables and the outcomes of such clinical trials;
-- the results of our clinical trials, including without limitation, with
respect to the safety and efficacy of VIA-2291;
-- the outcome of any legal proceedings;
-- our ability to obtain necessary FDA approvals;
-- our ability to successfully commercialize VIA-2291;
-- our ability to obtain and protect our intellectual property related to
our product candidates;
-- our potential for future growth and the development of our product
pipeline;
-- our ability to form and maintain collaborative relationships to
develop and commercialize our product candidates;
-- general economic and business conditions; and
-- the other risks described under the heading "Risk Factors" in our
Quarterly Reports on Form 10-Q for the quarters ended June 30, 2007
and September 30, 2007 on file with the SEC.
All forward-looking statements attributable to us or persons acting on
our behalf are expressly qualified in their entirety by the cautionary
statements set forth above. Forward-looking statements speak only as of the
date they are made, and VIA undertakes no obligation to update publicly any
of these statements in light of new information or future events.
VIA Pharmaceuticals
http://www.viapharmaceuticals.com
VIA Pharmaceuticals Enrolls Primul pacient din Faza 2 studiu clinic Pentru a mãsura impactul Din VIA-2291, pentru a reduce inflamarea vasculare - VIA Pharmaceuticals Enrolls First Patient In Phase 2 Clinical Trial To Measure Impact Of VIA-2291 To Reduce Vascular Inflammation - articole medicale engleza - startsanatate