Today, AtheroNova Inc. (AHRO-OTC) announced that it has initiated a Phase I clinical trial with AHRO-001, the Company’s lead compound. This milestone marks AtheroNova’s transition to a clinical-stage company. AHRO-001 is intended to treat and prevent atherosclerosis, a disease in which the buildup of cholesterol, fats, or other fatty substances along the walls of the arteries causes thickening, blockage, and hardening. Atherosclerotic plaque is the main cause of cardiovascular disease.
Currently, lipid regulators, specifically statins, are the most effective method for reducing serum cholesterol levels. However, at commonly prescribed dosage levels, statins are ineffective at reducing plaque, carry significant drawbacks in their tolerability, and may pose complications resulting from long-term use. Despite these disadvantages, the global market for lipid regulators was $38.7 billion as of 2011 (Source: IMS Health).
Nevertheless, a significant opportunity remains for effective and well-tolerated atherosclerosis therapies. Based on positive preclinical results to date, AtheroNova believes that AHRO-001 has the potential to treat and prevent atherosclerosis with an improved therapeutic profile over existing therapies. AtheroNova’s AHRO-001 is being developed to compete with lipid-regulating statins to become the new standard for reducing or eliminating atherosclerotic plaque.
The Phase I study is a randomized, double-blind, placebo controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of AHRO-001 in healthy adult volunteers. The study is being conducted in Russia with AtheroNova's licensing partner, OOO CardioNova, which is a subsidiary of the Maxwell Biotech Group (“Maxwell”). Maxwell is a development partner and financial resource for biotechnology companies. Maxwell has committed to funding Phase I and Phase II human clinical studies of AHRO-001 in Russia in return for up to $4.1 million in Common Stock and an exclusive license to develop and commercialize AHRO-001 in select territories within the Russian Federal and other former Soviet Republics. OOO CardioNova was founded by Maxwell to conduct clinical trials of AHRO-001, seek its approval, and then commercialize it in the territories covered by the license agreement.
Beyond AHRO-001, AtheroNova plans to develop multiple applications for its patented and patent-pending therapies in other markets that have been linked to atherosclerosis, including cardiovascular disease, stroke, peripheral artery disease, dementia, Alzheimer's, and erectile dysfunction.
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