New Technologies

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

Vascular endothelial growth factor (VEGF) is a protein that stimulates the growth of blood vessels. Biosidus 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 studies include: High-dose repeated administration of VEGF in patients with limb ischemia and intermitent claudication. Phase IIa. Catheter-mediated intramyocardial transendocardial injection of VEGF in patients with chronic heart failure. Phase IIb.

 

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