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Human Stem Cells Institute Licenses Its Innovative Ischemia Drug to ArtGen, Inc. for Development in the United States and Canada

ArtGen Inc. Partners with BioHealth Innovation, Inc.,to Advance First-in-Class Gene Therapy Drug, Neovasculgen®,for Treatment of Atherosclerotic Peripheral Arterial Disease (PAD) 

Moscow – October 12, 2016. PJSC HSCI – The Human Stem Cells Institute (“HSCI”, MOEX: ISKJ), a leading Eastern European biotech company, today announced that it has licensed the exclusive U.S. and Canadian rights for Neovasculgen® to ArtGen, Inc., a privately held biotechnology company located in Rockville, MD.

Neovasculgen® is a first-in-class gene therapy drug that was approved in 2011 for human use in Russia for treatment of atherosclerotic Peripheral Arterial Disease (PAD), including Critical Limb Ischemia (CLI). HSCI will receive milestone payments, royalties and future equity participation rights in ArtGen. 

ArtGen, in turn, is partnering with BioHealth Innovation, Inc. (BHI, http://www.biohealthinnovation.org/), a regional innovation intermediary focused on commercializing market-relevant bio-health innovations and increasing access to early-stage funding in Maryland, to develop a private-public partnership in the State of Maryland to advance the development of Neovasculgen. BHI will assist ArtGen in developing its scientific advisory board, creating operating teams and finding a contract manufacturing partner to advance the program into clinical trials.

Russian government granted Neovasculgen® reimbursement approval and included it in the List of Vital and Essential Drugs (VED) in 2016. It is a Vascular Endothelial Growth Factor (VEGF-165) plasmid vector drug with an action mechanism that uses an evolutionarily programmed process of blood vessel creation and growth (therapeutic angiogenesis).

“Russian scientists and researchers have spent 15 years on the development of Neovasculgen®,” said General Director of HSCI Artur Isaev, M.D. “Our investment and encouraging safety and efficacy data led to successful approval and market launch in Russia. Inclusion of Neovasculgen® in the VED list for 2016 will accelerate the accessibility and adoption of the drug.”

We are pleased to partner with ArtGen and support the company’s strategy to develop an approval path for the U.S. and Canadian markets,” said Richard Bendis, BHI President and CEO. “BioHealth Innovation is proud to help establish the U.S. company in Maryland and help with administrative, legal and other support to bring ArtGen’s novel products to market. BHI will leverage its network within the State of Maryland to facilitate the most seamless and efficient advancement of ArtGen’s therapeutic program.”

Neovasculgen® has shown long-term therapeutic effect and improved “Pain Free Walking Distance” by increasing the number of functioning capillaries in ischemic tissues and improved vascular function. It has further shown decreased rates of amputation and mortality in patients with lower limb ischemia, especially in patients with inoperable occlusive PAD.

“Therapeutic angiogenesis has much potential as a way of treatment for various diseases where the development of collateral blood flow is beneficial, and Neovasculgen® can be applied to treatment of a variety of ischemic conditions such as ischemic heart disease, diabetic neuropathy and trauma-induced peripheral nerve damage,” said ArtGen Chief Medical Officer Irena Tsyrlova. 

Full Version of the Press Release

12 October 2016