AtheroNova Completes Successful Pre-IND Meeting with FDA on AHRO-001 --Receives Guidance on Moving Lead Drug Compound to Clinical Trials--
IRVINE, Calif., Oct. 26, 2011 /PRNewswire/ -- AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, today announced that it has completed its pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). During the meeting, the FDA provided guidance on the development plan of AHRO-001, AtheroNova's lead patent-pending compound for the prevention and regression of atherosclerotic plaque. The goal of the pre-IND meeting was to obtain clarification on the nonclinical, clinical and chemical, manufacturing and control (CMC) requirements that need to be met in order to submit an acceptable IND.
"Our meeting with the FDA represents another important step in our clinical drug development plan. Our strategy to bring AHRO-001 into human clinical trials is now clear," said AtheroNova CEO Thomas Gardner. "Combined with our recent commitment from Maxwell Biotech Venture Fund to fund both Phase I and Phase II clinical trials and our licensing partnership with Maxwell Biotech Group, we are on track to commercialize novel therapies that can help millions of those suffering from cardiovascular disease."
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 Inc., through its wholly-owned subsidiary, AtheroNova Operations, Inc., is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits. The Company's focus on compounds to reduce or eliminate atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiovascular disease and stroke prevention. www.AtheroNova.com.
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 pipeline, milestones, future filings and trials, markets, mechanisms of action, licensing agreements and equity investment 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.