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AtheroNova Receives Russia’s Approval for Phase I Clinical Trials
Published Thursday, May 09, 2013 by Justin Kuepper
AtheroNova Inc. (OTCQB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and to improve lipid profiles in humans, has spent the last few months building up its scientific team ahead of clinical trials. And with Russia’s approval secured, the company is now ready to begin proving AHRO-001.

AHRO-001 is a novel drug for the treatment and prevention of atherosclerosis. Rather than just targeting cholesterol levels like Pfizer Inc.’s (NYSE: PFE) Lipitor® statin or Merck & Co.’s (NYSE: MRK) non-statin Zetia®, the company’s drug works by using a pharmacological compound to reduce cholesterol levels as well as potentially regress plaque deposits.

With heart disease responsible for 600,000 deaths per year in the U.S., there is a significant demand for drugs capable of reducing heart disease. In fact, statins alone are expected to reach $12.2 billion in global sales by 2018. AtheroNova’s AHRO-001 has the potential to revolutionize this market in a big way, making this clinical trial extremely important for investors to watch.

Read the full press release below:

AtheroNova Inc. (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.

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