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Skolkovo Biomedical Cluster Resident "CardioNova", founded with investments from Maxwell Biotech Venture Fund founded with the participation of RVC, announced today enrollment of the first volunteers with mild to moderate hyperlipidemia in a randomized, double-blind placebo controlled Phase I/IIa clinical trial. The study is aimed to assess safety, tolerability, pharmacokinetics and preliminary efficacy of a short-term reception of the lead compound AHRO-001. Approximately 70 patients will take part in this trial.
 
Skolkovo Biomedical Cluster Resident "CardioNova", founded with investments from Maxwell Biotech Venture Fund founded with the participation of RVC, announced today enrollment of the first volunteers with mild to moderate hyperlipidemia in a randomized, double-blind placebo controlled Phase I/IIa clinical trial. The study is aimed to assess safety, tolerability, pharmacokinetics and preliminary efficacy of a short-term reception of the lead compound AHRO-001. Approximately 70 patients will take part in this trial.
 
During the clinical trial will be studied the interaction between the projected drug AHRO-001 and atorvastin, the current “gold standard” in dyslipidemia therapy. The trial will be held in two Moscow study centers.
 
Cardiovascular diseases remain the biggest cause of deaths worldwide. One of the main factors for cardiovascular pathologies progression is dyslipidemia (increase in cholesterin level) that results in vessel arterial sclerotic disease. As a result, the risk for such acute ischemic conditions as myocardial infarction, apoplectic attack, as well as limb ischemia, increases considerably.
 
Preclinical studies, conducted in partnership with AtheroNova, a public US company, demonstrated that use of AHRO-001 resulted not only to a significant reduction in cholesterol levels, but also induced significant regression of atherosclerotic plaques reduction (by up to 94%) in the various vessels. No currently marketed drug has evidence of so strong potency in plaque regression. 

Andrey Boldyrev, CEO of “CardioNova”: “We are delighted that after the preclinical studies, which have shown safety and efficacy of AHRO-001, this clinical trial has started. The successful accomplishment of Phase I/IIa clinical trial can afford the company to move to the next efficacy phase of studies in patients, suffering from cardiovascular diseases”. 

About CardioNova
"CardioNova", Ltd is a private biotechnology company, founded in 2011 to develop and launch into the Russian market innovative products to treat cardiovascular disease. Since December 2011 “CardioNova” has become a resident of Skolkovo Biomed Cluster. The first product (AHRO-001) is aimed at treatment and prevention of atherosclerosis dysplipidemia and developed in the framework of international cooperation with public biotech company AtheroNova, Inc. (OTC: AHRO).
 
About Maxwell Biotech Group
Maxwell Biotech Group (MBG) is a development partner and financial resource for innovative biotechnology companies. MBG 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. Our unique business model can add value to our partners’ pipelines and provide a commercialization path to one of the most lucrative emerging markets. MBG relies on an experienced international team of managers and financial and industry experts. The Group includes 10 innovative biotechnological projects, developing in the portfolio companies: Oncomax, Photonics, Metamax, Infectex, NeuroMax, CardioNova, Hepatera, Osteros Biomedica, Eleventa.   All the group’s companies are the residents of the Biomed Cluster at Skolkovo Innovation Center and 5 of them are members of the Technology Platform “The Medicine of the Future”. 
 
For further information, please contact
Anna Sitnikova, Chief public relations Expert “Maxwell Biotech Group”
Tel. (495) 411-6992
 
About Russian Venture Company
RVC is a government fund of funds and a development institute of the Russian Federation, one of Russia's key tools in building its own national innovation system.
RVC was established by Russian Government on June 7, 2006 (Order No. 838-r). Its mission is to encourage Russia’s own VC industry and boost capital of VC funds. RVC’s role is that of a government fund of venture capital funds channeling public incentives to venture capital and financial support to the hi-tech sector, and of a Russian VC industry development institution.
RVC’s authorized capital — RUB 30 011 320 700 (about US$ 983.2 mln) — is 100% owned by the Federal Agency for State Property Management (Rosimuschestvo). RVC has backed 12 funds to a total capitalization of RUB 26.1 bln, its share amounting to RUB 16 bln. As on January 2013, RVC backed funds run a portfolio of 139 companies, invested capital totaling more than RUB 12.1 bln. 
For further information, please contact
Tel. (495) 411-6992
 

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.

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.

On April 11, at 19:30, the guest of Larisa Katysheva at the program “Tomorrow in the world”, going on air of Radio of Russia is Andrey Boldyrev, CEO of a Russian innovative biotech company CardioNova.

Andrey Boldyrev will talk about cardiovascular diseases, existing therapy standards and will address in detail the peculiarities and advantages of the drug designated for treatment of dislipidemy and preventive treatment of atherosclerosis, that is being developed by CardioNova.

On April 11, at 19:30, the guest of Larisa Katysheva at the program “Tomorrow in the world”, going on air of Radio of Russia is Andrey Boldyrev, CEO of a Russian innovative biotech company CardioNova.

Andrey Boldyrev will talk about cardiovascular diseases, existing therapy standards and will address in detail the peculiarities and advantages of the drug designated for treatment of dislipidemy and preventive treatment of atherosclerosis, that is being developed by CardioNova.

Andrey will also answer the presenter’s question on peculiarities of development of innovative biotech companies in Russia and support they get from the existing

On January 31, 2012, at the first partners’ meeting, organized by RVC, the ceremony of Venture Award 2011 was held. The hosts of the ceremony, Olga Orlova, editorial director of the Technopark programme, and Alexander Kostinsky, chief of the department of the RVC infrastructure development, gave prizes in 9 nominations devoted to different aspects of the activities of innovation companies and portfolio funds founded with the participation of RVC. The representatives of Maxwell Biotech Group became winners in 2 nominations.

On January 31, 2012, at the first partners’ meeting, organized by RVC, the ceremony of Venture Award 2011 was held. The hosts of the ceremony, Olga Orlova, editorial director of the Technopark programme, and Alexander Kostinsky, chief of the department of the RVC infrastructure development, gave prizes in 9 nominations devoted to different aspects of the activities of innovation companies and portfolio funds founded with the participation of RVC. The representatives of Maxwell Biotech Group became winners in 2 nominations.

In the Individual Contribution nomination the prize was given to Andrey Boldyrev, who is in charge of the dynamic development of two biotech companies MetaMax, Ltd CardioNova, Ltd. Dmitry Popov, managing partner at Maxwell Biotech Group, was awarded for his ability to turn discoveries and inventions into real business and was given the prize in the Transfer of Technologies and Practices nomination.

Photo: Andrey Boldyrev, CEO of the MetaMax, Ltd and CardioNova, Ltd, at the Venture Awards 2011 ceremony.

On December 19th, within the framework of the International Forum “Support for education, research and innovations in Skolkovo”, a regular grand ceremony for delivery of the resident status of the Skolkovo Innovative Center took place. At the Ceremony, a Russian biotech company CardioNova, one of portfolio companies of Maxwell Biotech Group, joined the Biomedical Cluster of the Skolkovo Innovative Center.

On December 19th, within the framework of the International Forum “Support for education, research and innovations in Skolkovo”, a regular grand ceremony for delivery of the resident status of the Skolkovo Innovative Center took place. At the Ceremony, a Russian biotech company CardioNova, one of portfolio companies of Maxwell Biotech Group, joined the Biomedical Cluster of the Skolkovo Innovative Center.

The goal of CardioNova is to develop and introduce to the Russian market innovative drugs aimed at preventive care and treatment of cardiovascular diseases. Not long ago CardioNova was invested by Maxwell Biotech Venture Fund created with the participation of the RVC capital. CardioNova has become the 6th company of Maxwell Biotech Group that joined Skolkovo.

Cardiovascular diseases remain the biggest cause of deaths worldwide. One of the main factors for cardiovascular pathologies progression is dislipidemy (increase in cholesterin level) that results in vessel arterial sclerotic disease. As a result, the risk for such acute ischemic conditions as myocardial infarction, apoplectic attack, as well as limb ischemia, increases considerably. Experts forecast that by year 2020 a number of people, dying from cardiovascular diseases, will reach 25 million per year. In Russia, annually over 1 million people die from diseases related to vessel arterial sclerotic disease, and about 400 thousand become invalid. Thus, the prevalence rate of such disease type represents not only serious medical but social and economic problem as well.

The first drug of CardioNova is aimed at treatment of dislipidemy and preventive treatment of atherosclerosis. The designed formula (AHRO-001) represents a low-molecular substance of C24 cholic acid family. Thanks to its physic-chemical parameters, the anticipated drug will be able to reduce significantly the cholesterin level in blood, as well as potentially reduce the size of atherosclerosis plaques. The first drug of CardioNova aimed at treatment of dislipidemy and preventive treatment of atherosclerosis is being developed in close cooperation with an American public biotech company AtheroNova, Inс (OTC: AHRO).

On November 17th, the investment committee of Maxwell Biotech Venture Fund created with the participation of RVC approved the essential terms and conditions including the amount of investments into CardioNova, Ltd, which goal is to develop and introduce to the Russian market innovative drugs for prevention and treatment of cardiovascular diseases. The first drug of CardioNova aimed at treatment of dislipidemy and preventive treatment of atherosclerosis is being developed in close cooperation with an American public biotech company AtheroNova, Inс (OTC: AHRO).

On November 17th, the investment committee of Maxwell Biotech Venture Fund created with the participation of RVC approved the essential terms and conditions including the amount of investments into CardioNova, Ltd, which goal is to develop and introduce to the Russian market innovative drugs for prevention and treatment of cardiovascular diseases. The first drug of CardioNova aimed at treatment of dislipidemy and preventive treatment of atherosclerosis is being developed in close cooperation with an American public biotech company AtheroNova, Inс (OTC: AHRO).

Cardiovascular diseases remain the biggest cause of deaths worldwide. One of the main factors for cardiovascular pathologies progression is dislipidemy (increase in cholesterin level) that results in vessel arterial sclerotic disease. As a result, the risk for such acute ischemic conditions as myocardial infarction, apoplectic attack, as well as limb ischemia, increases considerably. Experts forecast that by year 2020 a number of people, dying from cardiovascular diseases, will reach 25 million per year. In Russia, annually over 1 million people die from diseases related to vessel arterial sclerotic disease, and about 400 thousand become invalid. Thus, the prevalence rate of such disease type represents not only serious medical but social and economic problem as well.

Dmitry Popov, Managing Partner of Maxwell Biotech Venture Fund, believes that “the new project successfully complements the existing fund’s project line, aiming at solution of the most important problem of the present day healthcare”.

”The results of the preclinical efficiency research in animal models conducted in the leading world laboratories for studying arterial sclerotic disease problems seem to us very encouraging and we are happy to cooperate with AtheroNova team in further development of this highly promising drug”, — Dmitry Popov said.

The designed formula (AHRO-001) represents a low-molecular substance of C24 cholic acid family. Thanks to its physic-chemical parameters, the expected drug will be able to reduce significantly the cholesterin level in blood, as well as potentially reduce the size of atherosclerosis plaques.

This year, AHRO-001 has successfully completed the series preclinical trials in the California University and Cedars-Sinai Medical Center in Los-Angeles, as well as in the Cleveland clinic. The experiments confirmed the high efficiency of the drug; and in addition showed a significant reduction in the size of atherosclerosis plaques (up to 95%). According to experts, nowadays this therapeutic effect is inaccessible by any of the substance classes used for treatment of dislipidemy and preventive treatment of atherosclerosis.

Yan Ryazantsev, Director of the Department for investments and expert examination of RVC, noted: “This is not the first project in Maxwell Biotech Venture Fund portfolio, being developed in close cooperation with one of the foreign biotech companies, specializing in creation and introduction of innovative drugs to the market. Such cooperation, on the one part, reduces the fund’s risks, as the partner company’s team works according to the international standards of the pharmaceutical industry. The first results on preclinical efficiency have already been obtained, meeting all requirements of the international regulators, and we have based ourselves thereon in the decision-making process. It is also very importance that the process of further development and promotion of this drug by the Russian team will be led in close cooperation with AtheroNova experts that will allow our team build up muscles in the sphere of product development and commercialization on the global market. This aspect is also very important to us”.

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"CardioNova", Ltd is a private biotechnology company, founded in 2011 to develop and launch into the Russian market innovative products to treat cardiovascular disease. Since December 2011 “CardioNova” has become a resident of Skolkovo Biomed Cluster.