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Development of Russian innovative drug for Peripheral Arterial Disease is supported by the Council of Maryland Biotech Companies (USA)

Moscow – July 09, 2014 – OJSC HSCI – The Human Stem Cells Institute (“HSCI”, MICEX: ISKJ), one of Russia’s leading biotech companies, today announced that its novel gene-therapy drug for the treatment of Peripheral Arterial Disease (PAD) and its USA development plan has received support from the Business Innovation Network of Montgomery County, Maryland, USA (www.mcinnovationnetwork.com).

According to the Council’s resolution, made on May 1, 2014, the drug Neovasculgen® developed by Human Stem Cells Institute has been approved as a necessary treatment supporting the health of American citizens. The Germantown Incubator welcomed the development of groundbreaking drug Neovasculgen® in the USA and decided to provide full cooperation in developing the company and bringing this and other potential drugs to the American consumers.

For drug candidates like Neovasculgen®, aimed at treatment of serious, chronic and life-threatening diseases such as PAD with no effective treatments (Unmet Medical Need), FDA has recently developed accelerated programs (Fast Track Designation) in order to provide a speedy review and approval process.

With a 2010 prevalence of 17.6 million (www.thesagegroup.us), PAD is more common than coronary heart disease (16.3 million according to American Heart Association). According to the latest scientific data published on August 1, 2013 in "The Lancet" journal, the number of people with PAD has increased by almost 25% over the last 10 years reaching 202 million worldwide. The existing conservative therapy drugs require long courses of treatment and do not prevent the progression of the disease. In its severe form (Critical Limb Ischemia), the disease threatens a ¼ of all CLI patients with the danger of amputation. Neovasculgen® launches a new approach to treating ischemia – the use of an evolutionarily programmed process of formation and growth of collateral blood vessels. This mechanism of action is called therapeutic angiogenesis. The drug contains the gene of the Vascular Endothelial Growth Factor (VEGF) in a plasmid vector (carrier). By stimulating the formation and growth of collateral blood vessels, Neovasculgen® can provide a long-term therapeutic effect and improve patients’ quality of life. The development of the microvasculature in the ischemic tissue of the lower extremities promotes tissue oxygenation, healing of ulcers, and increases Pain Free Walking Distance. Neovasculgen®, successfully passed all the necessary preclinical studies and clinical trials, was approved and included in the State Registry of Medications in the Russian Federation (marketing authorization № LP-000671 of September 28, 2011).

There are currently 45 different drug candidates in various stages of research and clinical development for the treatment of PAD. According to data published by the research team CVRG in 2013, gene and cell therapy methods for the therapeutic angiogenesis were considered the main focus of companies that may provide a breakthrough therapy for PAD. It is important to note, that among many drugs being currently in development, only Neovasculgen® has demonstrated its efficacy in the treatment of PAD and is the only registered gene therapy PAD drug for use by consumers.

The US CRO company contracted by HSCI prepared and sent documents describing the plan of production, preclinical studies and clinical trials of Neovasculgen® to the FDA. According to the FDA response, there are no questions or criticisms made by the agency toward submitted data and proposed pre-clinical and clinical studies and the company is recommended not to hold a preliminary meeting, but rather to prepare directly for the pre-IND meeting with the FDA.

According to Artur Isaev, General Director of HSCI: “The company has sufficient data showing Neovasculgen’s efficacy, obtained in the course of clinical trials, uses of the drug in medical practice, and as a result of pharmacovigilance. This gives us additional confidence in the success of investing in development of the drug for new markets. The negotiations we conducted in early 2014 with the U.S. contract manufacturing companies (CMO) confirmed their willingness to cooperate with us. We feel an interest in the drug in the U.S., and look forward to an expedited review by the regulator of the results of preclinical studies and clinical trials of the drug. According to experts, the global gene therapy market will continue to grow. Currently, the drug Neovasculgen® we have developed has no competitors. We have all the prerequisites to take a majority stake and fulfill our growth potential together with the market. HSCI is holding a roadshow this July-August to attract investments, primarily for the development of Neovasculgen® in the U.S. and in China.”

Full Version of the Press Release (339 kb)


10 July 2014