Anginera™
Introduction
Theregen's primary corporate objective is the clinical development and approval of Anginera. Anginera initially will treat diffuse small vessel disease associated with myocardial ischemia and will serve as an adjunct to revascularization procedures that include coronary arterial bypass graft (CABG) surgery and percutaneous coronary angioplasty with stenting. Anginera also may have the potential to treat patients with reversible ischemia associated with chronic heart failure, a much larger market than diffuse small vessel disease.
Anginera is an epicardial cell-based therapy similar to Dermagraft™, an FDA-approved wound management product. This heart therapy may require two or more Anginera patches applied directly to the surface of the heart (epicardium) during conventional bypass surgery. Preclinical studies suggest that Anginera promotes angiogenesis and arteriogenesis (small blood vessel development) when placed onto the surface of a damaged heart. Anginera's technology platform uses human fibroblast cells cultured and grown on a three-dimensional bioabsorbable scaffold material to create a viable tissue. When applied as an epicardial patch to an ischemic area of the heart, the living tissue provides a source of the cytokines and growth factors needed to induce angiogenesis and tissue repair. The preclinical studies have also provided evidence that Anginera supports improved function in a chronic ischemic heart model. A major benefit of Anginera treatment may be the improvement of blood flow to areas of the heart that are not treatable by conventional revascularization therapies (e.g., CABG and stents).
Patient Need
About one half of all fatalities due to cardiovascular disease can be attributed to myocardial ischemia (MI), a type of coronary heart disease. Coronary arterial bypass graft (CABG) is an open-chest procedure used to treat patients with myocardial ischemia. Approximately 800,000 CABG procedures are performed on 447,000 patients worldwide each year, of which 516,000 procedures on 305,00 patients are performed in the United States. Between 40-60% of patients (approximately 150,000 patients) who undergo CABG procedures also suffer from related diffuse small vessel heart disease. Anginera is designed to complement conventional therapy, drugs and surgical methods.
The product's conservative annual worldwide potential market for treating diffuse small vessel heart disease is an estimated $0.8 billion. Anginera's broader applications to treat reversible ischemia associated resulting from chronic heart failure could significantly increase the market opportunity for this product.
Sources: American Heart Association (2002), Cleveland Clinic Heart Center, Minneapolis, Heart Institute, and Theregen estimates.
Next Generation Products
Theregen's technology asset acquisition strategy has provided a portfolio of patents and licenses that it believes will also enable development of follow-on products for several large cardiovascular and vascular markets. These next-generation therapies are intended be less invasive than Anginera and are intended to complement treatment of ischemic disease in the heart and periphery.