IRVINE, Calif., July 30, 2014 /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 that its
partner, CardioNova, has accomplished first dosing of subjects for
its Phase 1b clinical trial with AtheroNova's lead compound,
AHRO-001. This Phase 1b trial will be a continuation of the
AHRO-001 Phase 1 safety trial completed in February 2014, in which patients were dosed with
AHRO-001 for up to three weeks. The Company will remain
blinded to data from the earlier Phase 1 cohorts until the
completion of Phase 1b, at which time the topline data will be
presented together in approximately six to eight months.
"We are pleased to announce this important milestone for
AtheroNova's clinical development program," said Thomas W. Gardner, Chairman and Chief Executive
Officer of AtheroNova. "Much of what would typically be
studied in later phase clinical trials will be available to us in
this Phase 1b trial on an accelerated basis at a lower cost.
We will study the pharmacokinetic and pharmacodynamic effects of
twelve weeks of drug administration. We will look at markers for
inflammatory response, statin interaction and reverse cholesterol
transport, among others. This study will generate a wealth of
information in the near term as we anticipate topline data in 6-8
months."
The Phase 1b study will enroll 48 subjects to assess the safety,
tolerability and pharmacokinetics of AHRO-001 administered orally
three times daily in graduated dosing to both statin treated and
statin naïve, hypercholesterolemic individuals. The study
will evaluate lipid profiles, define gastrointestinal tolerability
and pharmacokinetics of graduated dosing for active transport
stimulation; as well as the hepatic cholesterol synthesis and
pharmacokinetics of co-administration of a statin with AHRO-001 in
some of the subjects in the study.
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 conducting 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. AtheroNova's lead compound,
AHRO-001, directly targets atherosclerosis. In addition to
its lead compound AHRO-001, AtheroNova has initiated its 505(b)(2)
application with the FDA for AHRO-002; 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 and Boston.
Forward-Looking Statements
This news release includes "forward-looking statements". 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 FDA, 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. Examples of forward-looking statements in this
release include statements regarding reduced data production in
connection with accelerated regulatory review, the Company's
expanded product portfolio, synergies and benefits from proposed
products and accelerated clinical development.
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 2013 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.