Coronary Artery Disease is the number one cause of death in the United States. It is estimated that 38% of all deaths are the result of a myocardial perfusion insufficiency. The FGF-1 drug advanced into US FDA-cleared Phase II clinical trials in this indication. ABC Nightly News did story on heat disease patients treated with FGF-1 at the University of Cincinnati Hospital. In this clinical trial, it was demonstrated that the drug could grow new blood vessels in the hearts of patients with serve coronary artery disease.
Zhittya Genesis Medicine believes that this treatment for severe coronary artery disease addressed an unmet medical need and would qualify for the FDA designation as a "Medical Breakthrough Therapy".
Since 1995, in four different human clinical trials, the FGF-1 molecule has demonstrated to be safe and to trigger the growth of new blood vessels in patients with coronary artery disease. It was demonstrated that patients had statistically significant improvement in their angina (chest pain) and functional improvement in treadmill exercise testing. The FDA clinical trials in this indication are complex and expensive, but Zhittya Genesis Medicine will be pursuing studies in this area and hope to be submitting an IND application.
This is the ABC Nightly News Story done on FGF-1 growing new blood vessels in the human heart in patients suffering with severe coronary artery disease.