RegeneRx Biopharmaceuticals has announced that the European Patent Office has issued a decision to grant a new patent for treating patients with peripheral neuropathy using Thymosin beta 4 (Tβ4). Tβ4 is the active pharmaceutical ingredient in RegeneRx’s proprietary drug candidate, RGN-352, a first-in-class injectable formulation designed for systemic administration.
An estimated 20 million people in the United States have some form of peripheral neuropathy, a condition that develops as a result of damage to the peripheral nervous system—the vast communications network that transmits information between the central nervous system (the brain and spinal cord) and every other part of the body. (Neuropathy means nerve disease or damage.) Symptoms can range from numbness or tingling, to pricking sensations (paresthesia), or muscle weakness. Areas of the body may become abnormally sensitive leading to an exaggeratedly intense or distorted experience of touch. Severe symptoms may include burning pain (especially at night), muscle wasting, paralysis, or organ or gland dysfunction. Diabetes mellitus is a common cause of peripheral neuropathy.
RegeneRx in-licensed the intellectual property relating to the use of Tβ4 from the Henry Ford Hospital System in Detroit, USA based on work performed by Michael Chopp and his colleagues.
RGN-352, the Company’s Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.