The Ministry of Health has registered the first genetic drug for the treatment of the consequences of a local blood supply disorder (ischemia). In the second quarter of 2012, the drug will appear in pharmacies and will probably be prescribed free of charge
On December 7, the Human Stem Cell Institute (HSCI) received a registration certificate for Neovasculgen ®, a Russian innovative drug for the treatment of lower limb ischemia (Registration certificate No. LP-000671). International non-proprietary name - Cambiogenplasmid.
This drug is a circular DNA molecule (plasmid) containing the human VEGF-165 gene. It encodes the synthesis of Vascular Endothelial Growth Factor (VEGF) and thereby stimulates vascular growth.
In the second quarter of 2012, after the completion of the certification process for batches of the drug, Neovasculgen® will be introduced to the retail and hospital markets as a finished drug (solution for injection, course - 2 injections / 2 packs /), HSCI reports. The planned production volume is up to 40 thousand packs per year.
During 2012, HSCI plans to formalize the entry of the drug into federal and regional programs for financing drug assistance to the population. This means that some Russians will be able to receive the drug for free.
“This event of special significance […] for the entire biotechnology industry in Russia and abroad […] opens up the prospect of a line of gene therapy drugs for the treatment of a number of diseases,” commented Artur Isaev, Director of the Institute. "HSCI will become the first company in Europe to commercialize a gene therapy drug and will continue to operate while maintaining its leadership in promoting gene therapy in the pharmaceutical market."
Artur Isaev said that the drug is likely to enter the CIS markets. Moreover, HSCI continues to develop new generations and modified versions of the gene therapy drug.
Gene of new vessels
New vessels are needed for patients with chronic and critical ischemia of the lower extremities (CINC and CINC, respectively), and there are more than 1.5 million of them in Russia.
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Ischemia (from the Greek. Ischo - delay, stop and háima - blood) is a local anemia, insufficient blood content in an organ or tissue caused by narrowing or complete closure of the lumen of the adducting artery.
CINC and CINC are a clinical manifestation of atherosclerosis. According to the Institute of Human Stem Cells (HSCI), about 1.5 million Russians suffer from chronic ischemia. The drugs used for conservative therapy do not stabilize the course of CINC, writes HSCI.
The diagnosis "KINK" is annually made to 144 thousand Russians, up to 40 thousand patients undergo amputation of limbs.