Key Ingredient in RegeneRx’s RGN-352 Treatment for MS Wins Australian Patent

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by Patricia Silva, PhD |

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Australia has granted a patent to RegeneRx Biopharmaceuticals for an active ingredient in a therapy that could benefit multiple sclerosis (MS) patients.

The patent is for Thymosin beta 4 (Tβ4), the driving force in the company’s RGN-352 treatment. RGN-352 promotes myelination, or the production of protective myelin sheaths for damaged neurons and other nerve cells associated with MS.

The protection that the Australian Patent Office granted to Thymosin beta 4 runs until March 26, 2030.

Dr. Michael Chopp and colleagues at the Henry Ford Hospital System in Detroit, MI, conducted much of the research that led to the patent.

MS is characterized by damage to the myelin sheath, a protective cover that surrounds the nerves of the central nervous system, including the brain, optic nerves, and spinal cord. The damage is caused by inflammation.

Myelin is made up of fatty lipids and proteins that help nerve cells transmit information faster and facilitate more complex brain processes.

Myelination is the process by which myelin is formed around nerve cells, or neurons. Since myelin allows nerve impulses to move more efficiently, it is vital to healthy central-nervous-system functioning.

Myelination holds significant promise as a strategy for restoring MS patients functioning, and reducing or stopping the progression of their disease.

RGN-352 is an injectable Tβ4 treatment for heart damage as well as nervous-system conditions.

Preclinical studies have demonstrated Tβ4’s potent regenerative and protective effects on the peripheral and central nervous systems.

In MS studies, RGN-352 increased production of oligodendrocyte precursor cells, which are responsible for myelin production, by more than 200 percent.

The compound doubled oligodendrogenesis — or the formation of oligodendrocytes — in the brain, restored neurological function by 50 percent, and reduced inflammatory infiltrates adjacent to brain vessels by 30 percent.

“This patent continues to expand the scope of potential use of RGN-352, our systemic formulation of Tβ4, in patients with neural injury and disease,” J.J. Finkelstein, RegeneRx’s president and chief executive officer, said in a press release. “The remyelination properties of Tβ4 found by Dr. Chopp and his team in their animal models suggests considerable potential for the use of Tβ4 in major disorders such as multiple sclerosis, as well as any other condition or disease that is associated with demyelination.”

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