AtheroNova Completes Enrollment in Phase 1 Clinical Trial of AHRO-001, a Potential Treatment for Atherosclerosis
IRVINE, Calif., Dec. 5, 2013 /PRNewswire/ -- AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces achievement of a major milestone with the completion of the active treatment portion of its Phase 1 clinical trial with its lead compound, AHRO-001. The Phase 1 study objective is to evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers. The clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.
"We are pleased to have reached this critical milestone as we continue to make solid progress," stated Thomas W. Gardner, CEO of AtheroNova. "With top line data anticipated in the first quarter of 2014 we are excited about near and long term prospects."
The Phase 1 study, with a planned enrollment of 54 subjects, was designed to characterize the safety of AHRO-001 across three dose ranges and possible pharmacokinetics. It is a multi-center, randomized, double-blind, placebo-controlled, single and multiple dose escalation, first-in-human study of AHRO-001 administered via oral tablet to healthy adult volunteers at sites in Moscow and St. Petersburg, Russia. All subjects have been dosed and received either placebo or AHRO-001 in doses ranging from 18.75 mg/kg to 37.5 mg/kg per day. Top line data is expected to be announced in the first quarter of 2014.
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. AtheroNova has shown positive results in animal models for regression of plaque and is now starting human studies in pursuit of these same successful results.
AtheroNova Inc. is a biotechnology company focused on the discovery, research, development and licensing of novel compounds to safely reduce or regress atherosclerotic plaque deposits and improve lipid profiles in humans. In addition to its lead compound AHRO-001, AtheroNova plans to develop multiple applications for its patented and patents-pending therapies in market sectors that include: Cardiovascular Disease, Stroke and Peripheral Artery Disease, 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 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.
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.
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.