IRVINE, Calif., Dec. 5, 2013 /PRNewswire/ -- AtheroNova Inc.
(OTCBB: AHRO), a biotech company focused on the research and
development of compounds to safely regress atherosclerotic plaque
and improve lipid profiles in humans, today announces achievement
of a major milestone with the completion of the active treatment
portion of its Phase 1 clinical trial with its lead compound,
AHRO-001. The Phase 1 study objective is to evaluate the
safety, tolerability and pharmacokinetics of AHRO-001 in healthy
volunteers. The clinical study is being conducted in Russia with AtheroNova's licensing partner,
OOO CardioNova.
"We are pleased to have reached this critical milestone as we
continue to make solid progress," stated Thomas W. Gardner, CEO of AtheroNova. "With top
line data anticipated in the first quarter of 2014 we are excited
about near and long term prospects."
The Phase 1 study, with a planned enrollment of 54 subjects, was
designed to characterize the safety of AHRO-001 across three dose
ranges and possible pharmacokinetics. It is a multi-center,
randomized, double-blind, placebo-controlled, single and multiple
dose escalation, first-in-human study of AHRO-001 administered via
oral tablet to healthy adult volunteers at sites in Moscow and St.
Petersburg, Russia. All subjects have been dosed and
received either placebo or AHRO-001 in doses ranging from 18.75
mg/kg to 37.5 mg/kg per day. Top line data is expected to be
announced in the first quarter of 2014.
About AHRO-001
AHRO-001 is AtheroNova's first novel
application for the treatment and prevention of atherosclerosis.
Atherosclerotic plaque is the primary, underlying cause of heart
disease and stroke in industrialized countries. AtheroNova has
shown positive results in animal models for regression of plaque
and is now starting human studies in pursuit of these same
successful results.
About AtheroNova
AtheroNova Inc. is a biotechnology
company focused on the discovery, research, development and
licensing of novel compounds to safely reduce or regress
atherosclerotic plaque deposits and improve lipid profiles in
humans. In addition to its lead compound AHRO-001, AtheroNova plans
to develop multiple applications for its patented and
patents-pending therapies in market sectors that include:
Cardiovascular Disease, Stroke and Peripheral Artery Disease, all
of which have been linked to atherosclerosis. Atherosclerosis and
its related pharmaceutical expenses for these indications cost
consumers more than $41 billion
annually in the United States
alone. For more information, please visit www.AtheroNova.com.
About OOO CardioNova
OOO CardioNova is an operational
company in the Russian Federation
founded by Maxwell Biotech Group to conduct clinical trials of
AHRO-001, seek its approval, and then commercialize it in the
territories covered by the license agreement.
About Maxwell Biotech Group
Maxwell Biotech Group is
a development partner and financial resource for biotechnology
companies. Maxwell provides investment capital and access to an
established infrastructure for conducting high-quality clinical
trials in Russia, and helps enable
the rapid and cost-effective achievement of clinical objectives.
Maxwell's unique business model can add value to its partners'
pipelines and provide a commercialization path to one of the most
lucrative emerging markets. Maxwell relies on an experienced
international team of managers and financial and industry experts,
with offices in Moscow,
Boston and San Diego.
Forward-Looking Statements
This news release
includes "forward-looking statements" within the meaning of the
safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. These statements are based upon the
current beliefs and expectations of AtheroNova's management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to,
general industry conditions and competition; significant
fluctuations in expenses associated with clinical trials, failure
to secure additional financing, the inability to complete
regulatory filings with the Food and Drug Administration,
general economic factors, including interest rate and currency
exchange rate fluctuations; the impact of pharmaceutical industry
regulation and health care legislation in the United States and internationally; global
trends toward health care cost containment; technological advances,
new products and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approval; AtheroNova's ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of AtheroNova's patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
AtheroNova undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in AtheroNova's 2012 Annual
Report on Form 10-K and the company's other filings with the
Securities and Exchange Commission (SEC) available at the SEC's
Internet site(www.sec.gov).
SOURCE AtheroNova Inc.