VIA Pharmaceuticals Announces First-in-Human Dosing of VIA-3196 for Treatment of Dyslipidemia
13 June 2011 - 10:00PM
Marketwired
VIA Pharmaceuticals, Inc. (PINKSHEETS: VIAP), a biotechnology
company focused on the development of compounds for the treatment
of cardiovascular and metabolic disease, today announced dosing of
the first healthy volunteers in a Phase I clinical trial of
VIA-3196, the Company's orally administered, liver-directed thyroid
hormone (THR) beta receptor agonist for the treatment of high LDL
cholesterol and other dyslipidemias including high triglycerides
and elevated Lp(a).
As a beta-selective THR agonist, VIA-3196 is designed to
specifically target receptors in the liver involved in metabolism
and cholesterol regulation, and avoid side effects associated with
THR activation outside the liver. In preclinical studies, VIA-3196
demonstrated a rapid reduction of non-HDL cholesterol,
triglycerides, and fatty liver, and synergistic activity when used
with statins.
"There remains a significant unmet need for new and more
effective therapies that reduce the lipids linked to heart disease,
particularly among high risk patients whose LDL cholesterol is not
controlled by current therapies," said Rebecca Taub, MD, Senior
Vice President, Research & Development for VIA Pharmaceuticals.
"By targeting a distinct mechanism of lipid metabolism, VIA-3196
has the potential to address hypercholesterolemia and other
dyslipidemias when given alone or in combination with other lipid
lowering agents. We are pleased that the first volunteers have been
dosed with the study drug and no adverse events have been
reported."
"Today's announcement is a significant milestone for VIA
Pharmaceuticals, and an important first step in the clinical
development of VIA-3196," said Lawrence Cohen, PhD, Chief Executive
Officer of VIA Pharmaceuticals.
The Phase I clinical trial of VIA-3196 (ClinicalTrials.gov ID:
NCT01367873) is an ascending single-dose study to evaluate the
safety, pharmacokinetics and pharmacodynamics of VIA-3196 in
healthy subjects. The single-center trial will enroll approximately
seventy-two subjects and is being conducted by Cetero Research at
its clinical study site in Fargo, ND. VIA-3196 was first developed
by Hoffmann-La Roche Inc. and inlicensed by VIA Pharmaceuticals in
December 2008.
About VIA Pharmaceuticals, Inc. VIA
Pharmaceuticals, Inc. is a biotechnology company focused on the
development of compounds for the treatment of cardiovascular and
metabolic diseases. VIA's drug candidates include VIA-3196 and
other compounds to address underlying causes of cardiovascular
disease: high cholesterol, diabetes and inflammation. 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.
Factors that may cause actual results to differ materially from
current expectations include, but are not limited to: our ability
to obtain necessary financing in the near term, including amounts
necessary to repay the 2009 loan from Bay City Capital following
the April 1, 2010 maturity date, and the 2010 loan, as amended,
from Bay City Capital by the September 30, 2011 maturity date (or
earlier if certain repayment acceleration provisions are
triggered); the safety and efficacy of VIA-3196; the complexities
in designing and implementing Phase 1 and Phase 2 clinical trials;
our ability to timely recruit and enroll patients in any future
clinical trials; our ability to obtain necessary FDA approvals; our
ability to successfully commercialize VIA-3196; 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 Item IA "Risk Factors" in our
Annual Report on Form 10-K for the fiscal year ended December 31,
2010 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
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