New Research Paper Suggests RegeneRx's Thymosin Beta 4 May be Useful in Treating COVID-19

ROCKVILLE, Md., Sept. 8, 2020 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration announced today that a multi-institutional team of scientists from eight American research centers published  a  research paper on new therapeutic approaches for COVID-19 in which they propose that Thymosin beta 4 (Tβ4), because of its ability to induce fibrinolysis, among other activities, may be useful in treating patients with the COVID-19 virus. According to the scientific team, an increase of fibrinolysis could be achieved by increasing ACE, or by administering Tβ4. Fibrinolysis is the breakdown of fibrin in blood clots and Tβ4 has been shown to prevent actin from binding to fibrin, which is a major component of blood clots.  Blood clots in the blood stream and organs of patients with COVID-19 have been shown to lead to extensive morbidity and patient death.

The researchers also found that COVID-19 elevates bradykinin levels in multiple tissues and systems that cause significant increases in vascular dilation, vascular permeability, and hypotension in infected patients. Previous studies have shown that elevated bradykinin levels induce pain and cause blood vessels to expand and become leaky, that can lead to swelling and inflammation of the surrounding tissue. This bradykinin-storm in COVID-19 patients induces leakage of fluid into the lungs and excessive release of hyaluronic acid preventing oxygen uptake and carbon dioxide release in the lungs of severely affected COVID-19 patients. These bradykinin-driven outcomes suggest that a bradykinin storm may be responsible for many of  the more severe symptoms of COVID.

In their study, the researchers also looked at differences in male/female morbidity and mortality and noted a number of interesting points linked with other studies. It is known that older age and a high number of co-morbidities are associated with increased severity and mortality in patients with COVID-19 and other similar infectious viruses such as  SARS. They reported that age was comparable between men and women in all data sets. In the case data series, men's cases tended to be more serious than women's (P = 0.035). In the public data set, the number of men who died from COVID-19 is 2.4 times that of women (70.3 vs. 29.7%, P = 0.016).  While men and women have the same prevalence, men with COVID-19 are more at risk for worse outcomes and death, independent of age.

"That men with COVID-19 are 2.4 times more likely than women to die from the virus is extremely interesting because the gene for Thymosin beta 4 resides on the X chromosome.  Women have two X chromosomes while men only have one.  As the researchers suggested, this could explain the lower incidence of COVID-19 induced mortality in women because it is found on the X chromosome and escapes X-inactivation. Women, therefore, would have increased levels of Tβ4 compared to men; thus, the possible explanation why women have an improved chance of survival.  If true, then administering pharmacological levels of Tβ4 to COVID-19 patients may significantly reduce morbidity and improve survival," stated Dr. Allan L. Goldstein, Professor Emeritus at the George Washington School of Medicine, Department of Biochemistry and Molecular Medicine in Washington, DC and Chairman and Chief Scientific Advisor of RegeneRx Biopharmaceuticals, Inc.  Dr. Goldstein was not involved in this research study.

"Additionally, the potential impact of Tβ4 in the treatment of COVID-19 merits further consideration as this, and other published studies, have shown Tβ4's ability to not only down-regulate inflammatory chemokines and cytokines and proinflammatory processes such as the bradykinin storm, but also increase fibrinolysis and accelerate wound repair in the heart, lungs, kidneys and other organs that are often affected by COVID-19 infection.  Moreover, previously published data have demonstrated a significant decrease of Tβ4 in blood, tears, and saliva with age in humans. Thus, finding a way to control and dampen this "storm" may be the key to successfully treating COVID-19 patients, especially in older and more vulnerable patients," said Dr. Goldstein. 

The research, entitled A mechanistic model and therapeutic interventions for COVID-19 involving a RAS-mediated bradykinin storm, was published in eLife 2020;9:e59177 DOI: 10.7554/eLife.59177.  The research was conducted by Michael R Garvin et al., at Oak Ridge National Laboratory, Biosciences Division, United States; University of Tennessee Knoxville, The Bredesen Center for Interdisciplinary Research and Graduate Education; University of Kentucky, Department of Horticulture; Versiti Blood Research Institute, Medical College of Wisconsin; VA Connecticut Healthcare/General Internal Medicine, Yale University School of Medicine; University of Cincinnati; Biomedical Informatics, Cincinnati Children's Hospital Research Foundation; University of Tennessee Knoxville, Department of Psychology, Austin Peay Building.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair, and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/TBI and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.  RGN-259, the Company's ophthalmic eye drop, is currently in phase 3 development in the U.S. for dry eye syndrome and neurotrophic keratitis.  The Company is also considering initiating a program to evaluate RGN-352, an injectable formulation of Tβ4, for the treatment of patients with COVID-19. The Company previously successfully completed phase 1 with RGN-352.

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SOURCE RegeneRx Biopharmaceuticals, Inc.

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