The Human Stem Cells Institute has received state approval for Neovasculgen – the first Russian gene-therapy drug to treat peripheral arterial disease. The drug’s international non-patented name is cambiogenplasmid.
The approval 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 the announcement, General Director of HSCI Artur Isaev said: “The registration of 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. Following the introduction of this drug, HSCI will become the first company in Europe to have commercialized a gene-therapy drug. 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.”
Date: December 6, 2011
Source: Human Stem Cells Institute www.hsci.ru