AtheroNova Announces Milestone with Initiation of Phase 1b Clinical Trial of AHRO-001 Anticipate Topline Data in 6-8 months
IRVINE, Calif., July 30, 2014 /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 that its partner, CardioNova, has accomplished first dosing of subjects for its Phase 1b clinical trial with AtheroNova's lead compound, AHRO-001. This Phase 1b trial will be a continuation of the AHRO-001 Phase 1 safety trial completed in February 2014, in which patients were dosed with AHRO-001 for up to three weeks. The Company will remain blinded to data from the earlier Phase 1 cohorts until the completion of Phase 1b, at which time the topline data will be presented together in approximately six to eight months.
"We are pleased to announce this important milestone for AtheroNova's clinical development program," said Thomas W. Gardner, Chairman and Chief Executive 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 twelve weeks of drug administration. We will look at markers for inflammatory response, statin interaction and reverse cholesterol transport, among others. This study will generate a wealth of information in the near term as we anticipate topline data in 6-8 months."
The Phase 1b study 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 naïve, hypercholesterolemic individuals. The study will evaluate lipid profiles, define gastrointestinal tolerability and pharmacokinetics of graduated dosing for active transport stimulation; 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.
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 conducting 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. AtheroNova's lead compound, AHRO-001, directly targets atherosclerosis. In addition to its lead compound AHRO-001, AtheroNova has initiated its 505(b)(2) application with the FDA for AHRO-002; 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 and Boston.
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 FDA, 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. Examples of forward-looking statements in this release include statements regarding reduced data production in connection with accelerated regulatory review, the Company's expanded product portfolio, synergies and benefits from proposed products and accelerated clinical development.
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).
SOURCE AtheroNova Inc.