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American Journal of Cardiovascular Drugs Features Article about HSCI’s Innovative Ischemia Treatment

Moscow – February 01, 2017. PJSC HSCI – The Human Stem Cells Institute (“HSCI”, MOEX: ISKJ), a leading Eastern European biotech company, today announced that in January 2017 the results of an international postmarketing surveillance study of Neovasculgen’s safety and efficacy were published in American Journal of Cardiovascular Drugs (doi:10.1007/s40256-016-0210-3:Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease).

Neovasculgen® is a first-in-class gene therapy drug developed by HSCI and approved in 2011 for human use in Russia for treatment of atherosclerotic Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI). In 2012 Neovasculgen® went on sales in the Russian market and in late 2015 was included in the List of Vital and Essential Drugs (VED).

In addition to the Russian market, HSCI intends to make its innovative ischemia drug available on other markets as well. In 2016 the agreements with the US partners were signed for the development of the drug candidate based on IP linked to Neovasculgen® in the United States and Canada.

The postmarketing surveillance study, which results are presented in the research article published in Am J Cardiovacs Drugs, was undertaken to evaluate the safety (identification of uncommon side effects) and efficacy of gene therapy in patients in routine clinical practice. It total, 210 patients with stage II-III chronic limb ischemia (according to the Fontaine-Pokrovsky classification) in 33 healthcare facilities in Russia and the Ukraine were enrolled in the study which makes it one of the largest among the clinical trials of gene therapy drugs.

The study indicated that the use of pl-VEGF165 in combination with standard pharmacological therapy significantly improves clinical signs of claudication in patients with chronic lower limb ischemia. The study results showed that the therapeutic effect was most prominent in patients with stage IIB and III disease. No angiogenic therapy-related adverse events or side effects were recorded.

Effective treatment of chronic lower limb ischemia is one of the most challenging issues confronting vascular surgeons. Current pharmacological therapies play an auxiliary role and cannot prevent disease progression, so new methods of treatment such as pl-VEGF165 (a gene therapy drug Neovasculgen®) are obviously needed.

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01 February 2017