CardioNova announced results from preclinical studies of its first experimental drug

CardioNova Ltd, a resident company of the Skolkovo Biomedical Cluster, has successfully completed pre-clinical safety and effectiveness studies of its lead compound AHRO-001, which is being developed in partnership with AtheroNova, a public US company, to treat dyslipidemia and prevent atherosclerosis.

Efficacy study was conducted in a standard animal model of atherosclerosis - mice with the inactivated gene of LDL cholesterol receptor, the so-called "bad" cholesterol (LDL-receptor-null (Ldlr-/-) mice). Such animals experience permanently high LDL cholesterol blood concentration resulting in accelerated plaque formation in the major arteries. Studies demonstrated that use of AHRO-001 resulted not only to a significant reduction in cholesterol levels, but also induced significant regression of atherosclerotic plaques (by up to 94%) in the various vessels. No currently marketed drug has evidence of so strong potency in plaque regression.

The study comparing effectiveness of AHRO-001 in the rat model of dyslipidemia against atorvastatin, the the current "gold standard" in dyslipidemia therapy,  showed that both agents are equally effective in controlling blood cholesterol levels. Pharmacokinetics and safety studies confirmed the earlier alleged absence of significant toxicity of AHRO-001, which, in contrast to statins, will be safe in humans, including dosages well above the expected maximum effective dose.

The results from pre-clinical studies have been partially published in leading scientific journals and were included in the registration dossier submitted by CardioNova to the Russian Ministry of Health to obtain permission for clinical research. In early 2013, the company expects to initiate phase I clinical trial investigating safety and pharmacokinetics of the agent in human volunteers.

Anna Zelenkova,
PR director with Maxwell Biotech Group;
Tel.: +7 (495) 411-6992

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