IRVINE, Calif., Nov. 13, 2012 /PRNewswire/ -- AtheroNova
Inc. (OTCBB: AHRO), a biotech company focused on the research and
development of compounds to safely regress atherosclerotic plaque
and to improve lipid profiles in humans, today announced that its
Russian licensing partner OOO CardioNova has formally submitted its
Investigational New Drug (IND) application with the Ministry of
Health of the Russian Federation
(Minzdrav). This filing is the first step in the process of
obtaining approval in Russia to
conduct the Phase 1 human clinical trials in the centers selected
by CardioNova. It is expected that the approval of the
application will be granted by the Ministry early in 2013 and the
Phase 1 will commence shortly thereafter.
"We are extremely gratified in achieving this milestone in our
path to human trials of AHRO-001," said AtheroNova CEO Thomas W. Gardner. "OOO CardioNova has
diligently pushed this filing forward with the utmost urgency and
we want to thank them for their efforts to complete this major step
in the process of clinical development of AHRO-001. We
continue to work aggressively toward our mutual goal of
commencement of Phase 1 clinical trials within the next 90
days."
"We are pleased to have such a tremendous business partner in
AtheroNova as we continue to endeavor toward approval of the Phase
1 protocol by the Ministry of Health," commented Dr. Alexey Eliseev, managing partner of Maxwell
Biotech Group, OOO CardioNova's parent company. "Our objective is
to work diligently with the Ministry of Healthcare for approval of
our submission while making final preparations for the commencement
of pre-screening and ultimately Phase 1 clinical trials in our
Russian study centers. We are excited with the prospect of
initiating clinical trials in anticipation of potentially
addressing one of the major health risks facing Russia, and throughout the world.
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. AHRO-001 uses certain pharmacological
compounds to regress atherosclerotic plaque deposits through a
process known as delipidization. Delipidization dissolves plaques
in artery walls, which are then removed by natural body processes.
AtheroNova is developing, and seeks to eventually market AHRO-001,
a product that has the potential to become a new standard of care
for patients prone to atherosclerotic plaque accumulation.
About AtheroNova
AtheroNova Inc., through its wholly-owned subsidiary, AtheroNova
Operations, Inc., is a biotechnology company focused on the
discovery, research, development and licensing of novel compounds
to reduce or regress atherosclerotic plaque deposits and to safely
improve lipid profiles in humans. In addition to its lead compound
AHRO-001, AtheroNova plans to develop multiple applications for its
patents-pending therapies in market sectors that include:
Cardiovascular Disease, Stroke, Peripheral Artery Disease, Dementia
and Alzheimer's and Erectile Dysfunction, 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 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.
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.
Forward-Looking Statements
Except for historical information contained herein, the
statements in this release are forward-looking and made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are inherently
unreliable and actual results may differ materially. Examples of
forward-looking statements in this news release include statements
regarding the Company's product shipments, suitability of the
compound for its intended use, mechanisms of action, clinical
trials and supply chain as well as the development of applications
for AtheroNova's technology. Factors which could cause actual
results to differ materially from these forward-looking statements
include such factors as 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, the introduction of competing
products, or management's ability to attract and maintain qualified
personnel necessary for the development and commercialization of
its planned products, and other information that may be detailed
from time to time in AtheroNova's filings with the United States
Securities and Exchange Commission. AtheroNova undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
SOURCE AtheroNova Inc.