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HSCI Receives Approval to Market Neovasculgen – the first Russian gene-therapy drug for Treatment of Peripheral Arterial Disease

Human StemCells InstituteMoscow, 7 December, 2011– OJSC HSCI – The Human Stem Cells Institute (“HSCI”, MICEX: ISKJ), Russia’s biotech company, announced today that it has received state approval for Neovasculgen® – the first Russian gene-therapy drug to treat Peripheral Arterial Disease.

The market authorization was received by HSCI on December 7, 2011, with the decision by the Russian Ministry of Healthcare and Social Development to include Neovasculgen® in the State Registry of Medications dating back to September 28, 2011. The decision was based on findings on the drug’s efficacy and safety reached during the pre-clinical and clinical trials carried out by HSCI. The Phase IIB/III clinical trials for Neovasculgen® were completed in Q2 2011, and in July HSCI submitted the relevant documentation to the Ministry for approval.

Sale of Neovasculgen® is scheduled to begin in Q2 2012 upon certification of the drug’s first batches. In 2012 HSCI will seek to include this new drug in federal and regional public medicine subsidy programs. Following  successful promotional activities, Neovasculgen® sales should account for a substantial portion of the Company’s revenues.

HSCI manufactures Neovasculgen® by contract basis in Russia.

Commenting on today’s announcement, General Director of HSCI Artur Isaev said: “Receiving of market authorization for Neovasculgen® is an event of particular importance not only for the Company but for the entire biotech sector in Russia and beyond. As a first-in-class drug, Neovasculgen® opens the horizon for a new generation of gene-therapy drugs for the treatment of a wide range of ailments. I would note that with the receiving of market authorization for Neovasculgen®, we have fulfilled an important part of our investment program unveiled during HSCI’s IPO. Following the launch of this drug, HSCI will become the first company in Europe to have commercialized a gene-therapy drug, thus reinforcing our status as a leader in the promotion of gene therapy on the pharmaceutical market. Neovasculgen® has enormous potential. This drug’s principle mechanism (therapeutic angiogenesis – stimulation of new blood vessel growth) makes it possible to treat ischemia in various places throughout the body.”

About Neovasculgen®
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). According to HSCI’s data, in Russia each year approximately 144,000 patients are diagnosed with CLI and 30,000-40,000 patients undergo amputations. The total number of patients diagnosed with PAD in Russia is estimated at 1.5 million. The prevailing conservative medical treatment of this disease requires a lengthy treatment procedure and is not effective in stemming the development of PAD.

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® is stimulating the growth of collateral blood vessels and, as a result, promotes a long-term therapeutic effect and improves patients’ life. For those with PAD, Neovasculgen® may help to increase Pain Free Walking Distance (PFWD), and for those with CLI, it may increase amputation-free survival. According to the results of clinical trials (concluded in November 2011), the therapeutic effects of Neovasculgen® last for two years at least. However, the drug’s effect is expected to last longer – observation of patients participating in clinical trials over the course of five years will be under way.     

 

Full Version of the Press Release (96 kb)

07 December 2011