VIA Pharmaceuticals and MHI Announce Publication of VIA-2291 5-Lipoxygenase Inhibitor Clinical Study Data in Circulation: Cardio
20 Maggio 2010 - 1:30PM
Marketwired
VIA Pharmaceuticals, Inc. (PINKSHEETS: VIAP), a biotechnology
company focused on the development of compounds for the treatment
of cardiovascular and metabolic diseases, and The Montreal Heart
Institute today announced the publication of clinical trial data
from a study of VIA-2291, a 5-Lipoxygenase inhibitor (5-LO), in
volume 3, issue 3 of the American Heart Association journal
Circulation: Cardiovascular Imaging, published May 19, 2010.
"Despite standard-of-care treatment, patients with recent acute
coronary syndromes remain at high risk of recurrent vascular
events, and this risk is greater in patients with evidence of
ongoing inflammation," said Dr. Jean-Claude Tardif, Director of the
Montreal Heart Institute Research Centre, professor of medicine at
the University of Montreal, principal investigator of the VIA-2291
ACS trial and the lead author of the publication. "VIA-2291 is
designed to target the underlying inflammatory disease process
active in atherosclerosis, including the reduction of leukotrienes,
an approach not addressed by currently available treatment. These
newly published data strongly support the evaluation of VIA-2291 in
larger outcome trials."
The publication includes data from VIA's ACS study, a
randomized, double-blind, placebo controlled Phase 2 study of
VIA-2291 in 191 patients who recently experienced acute coronary
syndromes (ACS), including heart attack or unstable angina.
Patients on standard care medications (statins, blood pressure
medications, and platelet inhibitors) were treated once daily for
12 weeks with one of three doses of VIA-2291 or placebo. The study
met its primary endpoint by demonstrating a statistically
significant, dose-dependent inhibition of whole blood stimulated
leukotriene LTB4 production at 12 weeks (P < 0.0001)
demonstrating greater than 80% inhibition in 90% of patients.
Leukotrienes are important mediators of inflammation believed to be
involved in the development and progression of atherosclerotic
plaque. VIA-2291 is designed to be a selective, potent and
reversible inhibitor of 5-LO, a key enzyme in the biosynthesis of
leukotrienes. A significant reduction of urine leukotriene LTE4, a
marker of systemic leukotriene production, was also obtained in all
dose groups, a secondary endpoint of the study. The drug was found
to be well tolerated, with no serious adverse events considered
related to study drug.
A subset of 93 patients were also evaluated in a 64-slice
coronary CT examination at baseline and at 24 weeks to study
VIA-2291's effect over a longer timeframe. Among evaluable
patients, new coronary plaques were observed in 5 of 18 (27.8%)
placebo and 2 of 42 (4.8%) VIA-2291-treated patients (P=0.01). A
reduction in non-calcified plaque volume at 24 weeks versus placebo
was observed in VIA-2291-treated groups in the patients in whom
this endpoint was analyzable (P < 0.01).
Although unchanged at 12 weeks in the main study, concentrations
of high-sensitivity C-reactive protein (hs-CRP), a validated marker
of inflammation and risk for cardiovascular diseases, were reduced
by 67% in the VIA-2291 100-mg treatment group relative to placebo
at 24 weeks (P=0.0002) among patients in the extension
sub-study.
The publication can be found on the American Heart Association's
website at http://circimaging.ahajournals.org.
About VIA Pharmaceuticals, Inc. VIA
Pharmaceuticals, Inc. is a biotechnology company focused on the
development of compounds for the treatment of cardiovascular and
metabolic disease. VIA's lead candidate, VIA-2291, targets a
significant unmet medical need: reducing inflammation in plaque,
which is an underlying cause of atherosclerosis and its
complications, including heart attack and stroke. In addition,
VIA's pipeline of drug candidates includes other compounds to
address other underlying causes of cardiovascular disease: high
cholesterol, diabetes and inflammation. For more information,
visit: http://www.viapharmaceuticals.com.
About the Montreal Heart Institute Founded
in 1954 by Dr. Paul David, the Montreal Heart Institute constantly
aims for the highest standards of excellence in the cardiovascular
field through its leadership in prevention, ultra-specialized care,
professionals training, clinical and fundamental research, and
assessment of new technologies. The Institute is part of a vast
network of excellence in health formed by the Université de
Montréal and its affiliated institutions. To learn more about the
Institute, please visit our website at www.icm-mhi.org.
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 find a market maker to apply and be cleared by
the Financial Industry Regulatory Authority to quote our common
stock on the OTC Bulletin Board;
- ability and willingness of active market makers in our common
stock to trade our common stock on the Pink Sheets under a
"piggyback qualification";
- our ability to borrow additional amounts under the new loan
from Bay City Capital, which is subject to the discretion of Bay
City Capital;
- our ability to obtain necessary financing in the near term,
including amounts necessary to repay the previous loan from Bay
City Capital following the April 1, 2010 maturity date;
- our ability to control our operating expenses;
- our ability to comply with covenants included in the loans from
Bay City Capital;
- our ability to operate following the implementation of our
strategic restructuring;
- our ability to comply with SEC reporting obligations following
our strategic restructuring;
- our ability to timely recruit and enroll patients in any future
clinical trials;
- our failure to obtain sufficient data from enrolled patients
that can be used to evaluate VIA-2291, thereby impairing the
validity or statistical significance of our clinical trials;
- our ability to successfully complete our clinical trials of
VIA-2291 on expected timetables and the outcomes of such clinical
trials;
- complexities in designing and implementing cardiometabolic
clinical trials using surrogate endpoints in Phase 1 and Phase 2
clinical trials which may differ from the ultimate endpoints
required for registration of a candidate drug;
- the results of our clinical trials, including without
limitation, with respect to the safety and efficacy of
VIA-2291;
- if the results of the ACS and CEA studies, upon further review
and analysis, are revised, interpreted differently by regulatory
authorities or negated by later stage clinical trials;
- our ability to obtain necessary FDA approvals, including to
initiate future clinical trials of VIA-2291;
- our ability to successfully commercialize VIA-2291;
- our ability to identify potential clinical candidates from the
family of DGAT1 compounds licensed and move them into preclinical
development;
- 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, including the THR beta agonist candidate and the
other compounds licensed from Roche;
- our ability to obtain strategic opportunities to partner and
collaborate with large biotechnology or pharmaceutical companies to
further develop VIA-2291;
- 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 Item IA "Risk Factors" in our Annual Report on Form
10-K for the fiscal year ended December 31, 2009 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.
Contact Information: VIA Pharmaceuticals, Inc. Lawrence
K. Cohen Chief Executive Officer 415.283.2209 Media contact: Andrea
Rabney Argot Partners 212.600.1902 Montreal Heart Institute Sylvain
Bouffard Director, Communications and partnerships 514-376-3330,
extension 3074 Email Contact
Grafico Azioni VIA Pharmaceuticals (CE) (USOTC:VIAP)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni VIA Pharmaceuticals (CE) (USOTC:VIAP)
Storico
Da Set 2023 a Set 2024