RegeneRx Biopharmaceuticals, Inc. reported that the first patent related to Thymosin beta 4 (TB4) for the treatment of Epidermolysis Bullosa (EB) has been issued in Australia.

The patent, which expires in 2022, claims numerous compositions, uses and processes related to the company's intellectual property. Similar patent applications have been submitted throughout the world for EB, as have applications regarding diverse properties, uses and compositions related to RegeneRx's technology platform beyond the wound healing field.

According to J.J. Finkelstein, RegeneRx's president and chief executive officer, "We have indicated since the start of our TB4 project that it has been our goal to invest heavily in expanding and protecting our intellectual property portfolio. The possibility that TB4, and its variants, have many applications as therapeutic and diagnostic agents requires construction of a comprehensive intellectual property portfolio to allow full development of these possibilities. This Australian patent is one of nearly 60 patent applications filed world-wide related to our technology platform, some of which we expect to be issued in the coming months. We believe such patents will significantly extend our proprietary position upon successful development of our drug candidates."

Epidermolysis Bullosa is a rare, and often devastating, genetic disease that has been designated an orphan indication by the US FDA. It is estimated that less than 50,000 in the US are affected with some type of EB, with a similar number in Europe. EB is characterized by the presence of extremely fragile skin and recurrent blister formation resulting from minor mechanical friction or trauma often associated with routine daily activity. These blisters develop into chronic, raw wounds that can also occur in the eye, mouth, and internal organs and tissues. In its most severe form EB is painful, debilitating, and requires constant care. The disorder occurs in every racial and ethnic group throughout the world and affects both sexes equally. Patients with the most severe form of EB produce less laminin-5, a protein that induces both adhesion and migration in a wide variety of cell types. Laminin-5 plays a key role in maintaining the structural integrity of the skin and is a vital protein needed for proper healing of wounds. In addition to accelerating wound healing, TB4 has been shown to increase the production of laminin-5.

TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. One of TB4's key mechanisms of action is its ability to regulate the cell-building protein, actin, a vital component of cell structure and movement.

Additionally, TB4 directly influences the production of laminin-5, a protein responsible for proper adhesion and migration of certain types of mammalian cells and often deficient in patients with EB. It has also recently been reported that TB4 can inhibit or prevent apoptosis (programmed cell death) in ocular tissue and cardiac tissue. Researchers at the National Institutes of Health, and at other academic institutions throughout the US, have published numerous scientific articles indicating that TB4 is effective in accelerating dermal and corneal wound healing in several animal models, under a variety of conditions. In an article published in the scientific journal, Nature, researchers found that TB4 protects heart tissue following a myocardial infarction (heart attack) in laboratory animals.