AtheroNova Announces Approval for Phase 1 by the Russian Ministry of Healthcare with Commencement of Human Trials Imminent Russian Licensing Partner Notified of Protocol Approval
IRVINE, Calif., May 9, 2013 /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 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."
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.
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of AtheroNova's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; 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, general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; AtheroNova's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of AtheroNova's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
AtheroNova undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in AtheroNova's 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
SOURCE AtheroNova Inc.