Gene Therapy | Angiogenesis and muscle regeneration using the vascular endothelial growth factor.

technological platforms

Vascular endothelial growth factor (VEGF) is a protein that stimulates the growth of blood vessels. Bio Sidus has developed the technology to generate naked plasmids containing the VEGF human gene in conditions suitable for administration to humans (i.e., pharmaceutical grade) with the aim of injecting them into the heart muscle in patients with perfusion disorders. Preclinical trials in animals showed successful reperfusion of ischemic areas and tissue regeneration with no toxic or undesirable side effects associated with this treatment.

Following very positive preliminary results we started Phase I clinical trials in humans involving ten patients GENESIS I: VEGF GENE Therapy for Severe ISchemic heart disease with myocardial viability. This consisted in the intramyocardial administration of plasmid DNA coding for rhVEGF165 in patients with severe coronary ischemic heart disease. A significant improvement of cardiac function, diminishment of angina, increase of the ejection fraction, and no serious side effects throughout patient follow-up were observed.

Projected clinical trials include a Phase II trial consisting in the plasmid injection in no-option patients with chronic ischemic heart disease; Phase II coronary artery bypass grafting combined with direct injection of plasmid in myocardial territories non amenable to surgical revascularization in patients with severe coronary heart disease, and a Phase I/II in severe limb ischemia.