Crystal Research Associates has released a Quarterly Update on AtheroNova Inc., a biotechnology company focused on the research and development of compounds that safely regress atherosclerotic plaque and improve patients’ lipid profiles. The 12-page report is available here.
Atherosclerotic plaque is a buildup of fat, cholesterol, and other substances. These plaque deposits, which progressively narrow and block the arteries, are the main underlying cause of cardiovascular disease, including heart attack, stroke, and peripheral artery disease (PAD).
Driven by a high prevalence of cardiovascular disease and limited therapeutic options, the global lipid regulator market reached $38.7 billion in revenues in 2011 (Source: IMS Health). Currently, lipid regulators, specifically statins, are the most effective method available for reducing serum cholesterol levels. At commonly prescribed dosages, however, they are not effective at significantly reducing atherosclerotic plaques, have drawbacks with tolerability, and may pose complications with long-term use.
AtheroNova plans to develop its patent-pending technology in multiple applications, including cardiovascular disease, stroke, PAD, dementia/Alzheimer’s, and erectile dysfunction—all of which have been linked to atherosclerosis.
AtheroNova's Lead Candidate Is Poised to Enter Phase I Human Clinical Trials
The Company’s most advanced candidate, AHRO-001, works to significantly reduce the incidence and severity of plaque by employing a bile salt to dissolve existing plaque deposits as well as prevent new deposits from forming. Bile salts are an FDA-approved natural compound used to dissolve gallstones.
In preclinical studies at UCLA and Cedars-Sinai to date, use of AHRO-001 has led to a 95% reduction in innominate arterial plaque formation versus the control group. The compound has not shown morbidity, adverse effects, or mortality, and was well tolerated at high doses.
AHRO-001 is progressing toward Phase I human clinical trials in Russia with the support of AtheroNova’s research and development partner, Russia-based OOO CardioNova, Ltd. OOO CardioNova has filed an Investigational New Drug (IND) application for AHRO-001 with Russia’s Ministry of Healthcare. Pending regulatory approval, AtheroNova anticipates that Phase I trials could be completed in 2013, followed by a Phase II clinical study. OOO CardioNova’s parent company, the Maxwell Biotech Group, has agreed to fund Phase I and Phase II clinical trials in Russia. The Company also plans to file an IND in the U.S. during 2013.
Establishing an Intellectual Property Portfolio for Lipid Modulation and Reduction
AtheroNova is focused on developing a comprehensive intellectual property portfolio to protect its lipid modulation and reduction technologies going forward, including for various compounds and administration techniques for treating atherosclerosis. In November 2012, AtheroNova achieved its first major step toward this goal with the receipt of a Notice of Issuance for its patent application #12/024,908, entitled “Dissolution of Arterial Plaque” (now U.S. Patent No. 8,304,383). This patent protects the Company’s lead candidate, AHRO-001, and aims to cover the use of hyodeoxycholic acid for atherosclerotic plaque lesions. AtheroNova’s partner, OOO CardioNova, submitted a similar filing on the Company’s behalf in the Eurasian markets.
AtheroNova Continues to Strengthen its Leadership
In recent months, AtheroNova has focused on expanding and strengthening its leadership team as the Company seeks approval for and prepares to initiate clinical trials. In particular, AtheroNova has appointed Mark K. Wedel, M.D., J.D. as its senior vice president of clinical affairs and chief medical officer. Dr. Wedel has expertise in the development and clinical affairs of lipid-modulating drugs. As well, the Company has selected Joan E. Shaw, MT (ASCP) (medical technologist, certified by the American Society for Clinical Pathology) as senior director of clinical operations. Ms. Shaw brings extensive clinical operations experience, including for AstraZeneca’s ASTEROID trial for the statin Crestor®. AtheroNova also expanded its Board of Directors with the addition of Mr. Fred Knoll, the principal and portfolio manager of Knoll Capital Management. Biographies for these individuals are provided on pages 7-8 of AtheroNova's Quarterly Update.
For additional information about the Company's technology, news announcements, and stock information, as well as to download published research reports, please see AtheroNova's Corporate Profile.