Gene Biotherapeutics is at the forefront of developing innovative DNA-based biotherapeutics aimed at treating cardiovascular diseases, particularly through their lead product candidate, Generx [Ad5FGF-4]. This therapy focuses on cardiac angiogenic gene therapy, which enhances blood flow and oxygen supply to ischemic cardiac tissue by promoting the growth of microvasculature. The company is currently conducting a Phase 3 clinical trial, known as the AFFIRM study, to evaluate the efficacy of a one-time administration of Generx in patients suffering from refractory angina due to late-stage coronary artery disease. This treatment is administered via an intracoronary infusion, allowing for targeted delivery to the heart.

The underlying technology of Gene Biotherapeutics revolves around a novel approach termed "medical revascularization," which employs a DNA-based therapeutic platform. This platform utilizes fibroblast growth factor-4 (FGF-4) in conjunction with an adenovirus gene delivery system to stimulate the body's natural angiogenic processes. By enhancing arteriogenesis and angiogenesis, the therapy aims to restore blood flow to ischemic tissues, not only in the heart but also potentially in other areas affected by ischemia. The clinical findings suggest that cardiac ischemia plays a crucial role in facilitating the transfection of Generx into heart cells, thereby supporting the formation of collateral blood vessels essential for effective treatment outcomes.

United States

Gene Biotherapeutics is a biotechnology company that focuses on the clinical development and commercialization of DNA-based biotherapeutics for the treatment of cardiovascular disease.

Gene Biotherapeutics

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