IRVINE, Calif., May 28, 2014 (GLOBE NEWSWIRE) -- 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 announced that its partner, CardioNova, received approval from the Russian Ministry of Healthcare to begin a Phase 1b clinical trial extension for AHRO-001. This Phase 1b trial will be a continuation of the successful AHRO-001 Phase 1 safety trial completed in February 2014, in which patients were dosed with AHRO-001 for up to three weeks.
"We are pleased to announce this important milestone for AtheroNova's clinical development program," said Tom Gardner, Chief Executive Officer of AtheroNova. "We are incorporating many standard Phase 2 clinical objectives into this 12-week Phase 1b dosing extension study, saving critical development time in the process. In addition to an early look at pharmacodynamics, we will also investigate critical biomarkers related to the significantly increased reverse cholesterol transport we've previously demonstrated in preclinical studies for AHRO-001. This accelerated development strategy will provide more data in a shorter period of time than traditionally expected."
"This is an essential study and an integral part of our clinical development plan for AHRO-001," remarked Randolph Johnson, PhD, Chief Operating Officer of AtheroNova. "Much of what would typically be studied in later phase clinical trials will be available to us in this Phase 1b trial on an accelerated basis at a lower cost. We will study the pharmacokinetic and pharmacodynamic effects of three months of administration, in addition to statin interactions, all of which are critical markers related to cardiovascular and metabolic health."
The Phase 1b study, commencing in the next six weeks, will enroll 48 subjects to assess the safety, tolerability and pharmacokinetics of AHRO-001 administered orally three times daily in graduated dosing to both statin treated and statin naive individuals, including some with hypercholesterolemia. The study will evaluate lipid profiles; define gastrointestinal tolerability and pharmacokinetics of graduated dosing for active transport absorption; as well as the hepatic cholesterol synthesis and pharmacokinetics of co-administration of a statin with AHRO-001 in some of the subjects in the study.
About AtheroNova
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. AtheroNova's lead compound, AHRO-001, directly targets atherosclerosis. 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 CardioNova
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.
Forward-Looking Statements
This news release includes "forward-looking statements". 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 2013 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).