Posted on: 21 December 2011, source: Human Stem Cell Institute (HSCI), Dr. Isaev
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 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.