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HSCI Starts Sales of the First Russian Innovative Drug for Treatment of Peripheral Arterial Disease

The Human Stem Cells Institute (“HSCI”, MICEX: ISKJ), one of Russia’s leading biotech companies, today announced that certification of Neovasculgen’s first batches has been completed and the drug will go to market before the end of September.

Neovasculgen® will be sold in the form of lyophilisate to prepare an injection solution; one treatment course – 2 sequential injections /i.e. 2 vials/). The drug will be available on the retail market as well as sold to hospitals in Russia via a network of distributors.

HSCI received marketing authorization for Neovasculgen® on December 7, 2011. The Russian Ministry of Healthcare and Social Development (RMHSD) decided to include the drug in the State Registry of Medications based on findings on the drug’s efficacy and safety reached during the pre-clinical studies and clinical trials.

HSCI manufactures Neovasculgen® by contract basis in Russia: the contractor is the Research Center for Hematology of the RMHSD.

In future this new drug will be possibly included in federal and regional public medicine subsidy programs. In addition to Russia, future plans entail bringing Neovasculgen® to other CIS markets as well as studying the possibility of introducing it in the European Union and United States. The process of obtaining marketing authorization for the drug in Ukraine began in March 2012.

Neovasculgen® is designed to treat Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI), caused by atherosclerosis (a thickening of artery walls and subsequent reduction of blood flow). While there are no official statistics on PAD in Russia, according to HSCI’s estimates no less than 1.5 million citizens suffer from this ailment. In Russia each year approximately 144,000 patients are diagnosed with CLI and 30,000-40,000 patients undergo amputations.

Neovasculgen® is a drug whose action mechanism – therapeutic angiogenesis – introduces a new approach to treating ischemia. The drug contains the gene of the Vascular Endothelial Growth Factor (VEGF) embedded in a plasmid vector (carrier). Neovasculgen® stimulates the growth of collateral blood vessels and, as a result, promotes a long-term therapeutic effect and improves patients’ life. The therapeutic effect following a treatment course of Neovasculgen® continues for up to two years. The observation of patients participating in the clinical trials over the course of two years concluded in November 2011 and the results will be published soon. It is suggested that the drug’s mechanism of action can provide an even longer effect – observation of patients will continue over the course of five years from the initial treatment.

As Neovasculgen® is the first-in-class gene-therapy product for PAD treatment via stimulation of angiogenesis, the drug has much potential for use in treating other conditions where the development of collateral blood flow is beneficial. At the moment, HSCI is preparing clinical trial protocols in order to expand the range of indications for applying Neovasculgen® (including other nosologies, such as ischemic heart disease /IHD/ and amyotrophic lateral sclerosis /ALS/). The Company also aims to create new gene-therapy drugs based on different constructions and genes, maintaining its status as a leader in the development and promotion of gene therapy on the pharmaceutical market.

Full Version of the Press Release (233 kb)

21 September 2012