IRVINE, Calif., May 9, 2013 /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 CardioNova has received written
notification of approval of the Phase 1 protocol in its
Investigational New Drug (IND) application with the Ministry of
Healthcare of the Russian
Federation (Minzdrav). This notice clears CardioNova
for distribution of the Phase 1 protocol to the participating
clinical centers and application for its license to import AHRO-001
to conduct the Phase 1 trial. CardioNova expects to obtain
approval of its importation license in the next few weeks and
commencement of patient screenings once drug product is in the
control of the clinical research organization (CRO) conducting and
monitoring the Phase 1 trial.
"We are thrilled to announce the achievement of another key
milestone and we are now within weeks of commencement of human
trials of AHRO-001," said AtheroNova CEO Thomas W. Gardner. "Our partner CardioNova
has been working tirelessly to ensure the fastest possible
turnaround on any requests for supplemental information and we
thank them for the extraordinary effort on this critical
approval. We have finished the packaging and labeling of
AHRO-001 and eagerly await the notification of the approval for
importation into the Russian
Federation."
"We are delighted to have achieved this milestone approval for
AHRO-001 and to be able to initiate clinical development of this
exciting compound," commented Dr. Alexey
Eliseev, Managing Director of Maxwell Biotech Group,
CardioNova's parent company.
"We are excited that our many months of planning and effort will
shortly result in the initiation of human clinical trials,
potentially addressing one of the major health risks facing both
Russia and the rest of the world,"
remarked Andrey Boldyrev, General
Director of CardioNova. "We are currently working with the CRO and
the trial centers to distribute the approved protocol and making
final preparations for the initiation of pre-screening and
ultimately Phase 1 clinical trials in our Russian study
centers."
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
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.