AtheroNova Announces Milestone Filing of IND in Russian Federation
Licensing Partner formally applies to the Ministry of Healthcare
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.
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.
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.
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.
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