INSTITUT : HSCI’s Innovative Neovasculgen® Drug Included into Vital and Essential Drugs List in Russia

Moscow, 11 January 2016. PJSC HSCI - The Human Stem Cells Institute ('HSCI', MOEX: ISKJ), one of Russia's leading biotech companies, today announced that its innovative drug Neovasculgen® was included in the List of Vital and Essential Drugs (VED) for 2016 in Russia (according to the government directive № 2724-р of 26 December 2015). The drug was included in the VED list under the name 'Plasmid Deoxyribonucleic acid [supercoiled circular double-stranded]'.

Neovasculgen® is the first-in-class gene-therapy drug whose action mechanism - therapeutic angiogenesis - introduces a new approach to treating ischemia: the use of an evolutionarily programmed process of blood vessel creation and growth. Developed by HSCI for treatment of atherosclerotic Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI), Neovasculgen® contains the gene of the Vascular Endothelial Growth Factor (VEGF 165) embedded in a plasmid vector (carrier) and thereof stimulates the growth of collateral blood vessels and, as a result, promotes a long-term therapeutic effect and improves patients' quality of life. Neovasculgen® received marketing authorization in 2011, and in 2012 was launched in the Russian market.

The Vital and Essential Drugs (VED) List is a register of pharmaceutical drugs approved by the Russian Government in order to provide state control over prices to increase availability of essential medicines to the people of Russia. The VED List mainly serves as the basis for drug purchases by hospitals and for recommended treatments of various diseases.

Artur Isaev, General Director of HSCI, commented: 'Inclusion of Neovasculgen® into the VED List was supported by the special commission and chief experts of the Russian Ministry of Health. A great deal of work was carried out by various experts to assess Neovasculgen's clinical safety and efficacy as well as its pharmacoeconomics. The drug was developed in Russia and it is manufactured in Russia, and its inclusion into the VED List not only leads to the improvement of patients' quality of life (for whom there was no efficient therapy before), but also brings import substitution effect leveraging state budget savings. For HSCI it is an important milestone which encourages us as a Russian R&D company and opens new opportunities to make the drug more available in Russia and to launch it abroad.'

Today the main approach to treatment of critical low limb ischemia is considered to be surgical revascularization. But a part of patients diagnosed with CLI is inoperable. Neovasculgen® stimulates the growth of collateral blood vessels (аngiogenesis) and therefore induces collateral blood circulation in ischemic tissues. The pioneers in development of this treatment approach were well-known Russian clinicians: Academicians Dr. Leo Bokeria and Eugeny Chazov, Professor Alexander Gavrilenko, and also biologists - Sergey Kiselev, Marina Eremeeva, Academician Vsevolod Tkachuk, Elena Parfenova and others.

According to the drug's clinical trial results and more than 3-year track of its use in practical healthcare, Neovasculgen® increases the functioning capillaries number in ischemic tissues, improves the blood supply as well as reduces the rate of amputation and mortality in patients with lower limb ischemia, especially in those who are inoperable for an occlusive PAD.

Peripheral Arterial Disease (PAD) is a serious, incapacitating disease, which is exceeded in frequency (amongst cardiovascular diseases) only by ischemic heart disease (IHD) and brain stroke. 202 million people are diagnosed with PAD worldwide. PAD is characterized by thickening of artery walls and subsequent reduction of blood flow to the lower limbs due to atherosclerosis.

In late December 2014, the expert panel of the Agency for Strategic Initiatives (the autonomous non-profit organization established by the Government of Russia in order to implement set of measures in economic and social spheres) has reviewed and approved HSCI's program 'The production and marketing of the innovative pharmaceutical drug Neovasculgen®'. At the moment, the ASI patronages this program and renders support in elaboration and adoption of new state medical care standards for the PAD treatment taking into consideration the new type of therapy by applying Neovasculgen®.

Therapeutic angiogenesis has much potential as the way of treatment for various diseases where the development of collateral blood flow is beneficial, therefore Neovasculgen® could be in demand for treating a variety of ischemic conditions. For this reason HSCI is now preparing to implement new clinical trial protocols in order to expand the range of indications for applying the drug. HSCI aims to work in the therapy of IHD (Ischemic Heart Disease), Diabetic Foot Syndrome and treatment of trauma-induced peripheral nerve damage.

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