FDA Agrees With AtheroNova's Clinical Development Plan as Proposed
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."
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.
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.
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.