IRVINE, Calif., Dec. 14, 2011 /PRNewswire/ -- AtheroNova
Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the
research and development of compounds to regress atherosclerotic
plaque has established a clear development plan, including Phase I
and Phase II protocol outlines, based on the recently finalized
minutes of its pre-IND (Investigational New Drug) meeting with the
U.S. Food and Drug Administration (FDA) for its AHRO-001, a
compound for the treatment of atherosclerosis. The Company
has incorporated guidance from the FDA and is moving forward with
its IND enabling activities. In addition, the sourcing and
production of the Active Pharmaceutical Ingredient (API) is
progressing according to schedule.
"As a result of the supportive feedback from the FDA, we have
established a clear development plan for AHRO-001, including Phase
I and Phase II human clinical studies." said Thomas W. Gardner, CEO of AtheroNova.
"Based on the success of our interactions with the FDA,
AtheroNova plans to move forward with the submission of the IND
application during 2012, as planned."
"The imaging of plaque lesions has made significant strides in
the last few years and AtheroNova is planning to use the state of
the art combination of intravascular/near-infrared spectroscopy as
a critical measurement tool for the regression of coronary artery
disease when moving forward with its Phase I and Phase II studies,"
said Balbir Brar, DVM, PhD; SVP,
Drug Development of AtheroNova. "Critical information of the
coronary plaque morphology and lipid content will assist in the
measurement of clinical progress of this and future therapies in
plaque management. We appreciate FDA's suggestions in
AtheroNova's study outlines and acceptance of
intravascular/near-infrared spectroscopy use in evaluating plaque
reversibility."
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 natural 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
plans to develop multiple applications for its patents-pending
compounds that can be used in pharmaceutical-grade products for the
treatment of atherosclerosis. Atherosclerosis and related
pharmaceutical costs run more than $41
billion annually in the United
States alone. Market sectors potentially served by AHRO-001
include: Cardiovascular Disease, Stroke, Peripheral Artery Disease,
Dementia and Alzheimer's and Erectile Dysfunction, all of which
have been linked to atherosclerosis.
About AtheroNova
AtheroNova, through its wholly-owned subsidiary, AtheroNova
Operations, Inc., is a development stage company currently
researching novel patents-pending applications of certain natural
compounds to regress atherosclerotic plaque deposits, a process
called delipidization. The Company plans to develop multiple
applications for its compounds, to be used in pharmaceutical grade
products for the treatment of atherosclerosis, obesity and
lipomas.
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 FDA guidance, filing of an IND application, clinical
measurement of plaque using intravascular/near-infrared
spectroscopy and Phase I and II clinical studies, and 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.