AtheroNova’s most advanced compound in development, AHRO-001, is a proprietary compound administered via a tablet. Through a process called delipidization, the compound is designed to dissolve plaque within the walls of the arteries and, subsequently, safely remove it from the body through natural metabolic processes. The compound also shows significant lipid panel improvement and has an effect on HDL efficiency. The Company is initially targeting individuals with lipid panels not at target with accompanying soft vulnerable plaque, as the volume of plaque that one accumulates over a lifetime can remain until death, with no truly effective way to reduce it. AHRO-001 potentially works in a manner that some have likened to “nature’s detergent”.
AtheroNova is developing AHRO-001 to directly compete with statins that largely lower cholesterol and stabilize plaque. In preclinical studies, AHRO-001 did not show adverse effects, including morbidity or mortality. Also, it was well tolerated at high doses—something that has been confirmed by other compounds in this family. Ursodiol, a pharmaceutical based on another naturally occurring compound and in the same compound family as AHRO-001, is used to treat gallstone dissolution and is the only U.S. Food and Drug Administration (FDA)-approved drug to treat primary biliary cirrhosis (PBC), with millions of patients taking it without significant side effects.
Company News AtheroNova Announces Preliminary Positive Phase 1 Clinical Data From Lead Drug AHRO-001, a Potential Treatment for Atherosclerosis Download PDF
IRVINE, Calif., Feb. 27, 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 the release of preliminary findings from its Phase 1 clinical trial with its lead compound, AHRO-001. The clinical study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova.
"We are encouraged by the preliminary Phase I data for AHRO-001 which represents another important milestone in our history," said Thomas Gardner, CEO of AtheroNova. "The encouraging safety and tolerability profile will allow AtheroNova and our clinical trial partner, OOO CardioNova, to move forward with our Russian clinical development plans."
The randomized, double-blind, placebo-controlled study enrolled more than fifty subjects and was conducted in Moscow, Russia. Designed to characterize the safety, tolerability and pharmacokinetics of orally administered AHRO-001 in volunteers, all study subjects have completed dosing and follow-up. Data remain blinded at this time pending additional regulatory filings.
"While preliminary, these findings are certainly promising and support further development," said Mark K. Wedel, MD, Chief Medical Officer at AtheroNova. "The safety data is unequivocal and is definitely encouraging. In addition, the trial yields valuable information about the tolerability of AHRO-001."
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 has shown positive results in animal models for regression of plaque and AtheroNova has initiated human clinical studies of AHRO-001 in pursuit of these same successful results.
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. 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 Biotech 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 Biotech'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 Biotech relies on an experienced international team of managers and financial and industry experts, with offices in Moscow and Boston.