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RegeneRx's T?4 Promotes Autophagy and Repair in Chronic Granulomatous Disease Model

RGRX

ROCKVILLE, Md., Nov. 14, 2019 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or the "Company"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced the publication of a new scientific study demonstrating how Thymosin beta 4 (Tβ4) promotes the body's ability to clean out damaged cells in order to regenerate newer, healthier cells (autophagy) and repair damage in chronic granulomatous disease (CGD).  

According to the publication, researchers demonstrated in vitro that certain proteins under-expressed in CGD patients were normalized by Tβ4 and promoted autophagy and up-regulation of genes involved in mucosal barrier protection.  In an in vivo study described in the paper, inflammation and granuloma formation were reduced and survival increased in mice with colitis and aspergillosis upon treatment with Tβ4.

CGD is a rare inherited primary immunodeficiency disease that increases the body's susceptibility to infections caused by certain bacteria and fungi. Granulomas are masses of immune cells that form at sites of infection or inflammation. The disorder is characterized by an inability to resist infections caused by certain types of bacterial and fungal species and a tendency to develop chronic inflammation.  Life-threatening recurrent fungal and bacterial infections affecting the skin, lungs, and bones may occur along with swollen areas of inflamed tissues known as granulomas that can be widely distributed. Symptoms usually begin in infancy or childhood. It is estimated that about four to five in every million people worldwide have chronic granulomatous disease, thus, it is considered an "orphan" disease.  According to the authors, Tβ4 may be useful in treating patients with CGD.

The research was performed by Dr. Giorgia Renga et. al at the Departments of Experimental Medicine, Internal Medicine, and Veterinary Medicine, University of Perugia, Italy; Department of Pediatrics, Children's Hospital Bambino Gesù, Rome, Italy; University San Raffaele and Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, Rome, Italy; and the Department of Biochemistry and Molecular Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC. The article was published online in the journal, Life Science Alliance, 12 November, 2019 | Supp Info: http://doi.org/10.26508/lsa.201900432.

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 and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.

RegeneRx, through its U.S joint venture, ReGenTree LLC, is sponsoring a follow-up phase 3 clinical trial (ARISE-3) in approximately 700 patients with dry eye syndrome (DES) designed to confirm statistically significant results from ARISE-2 a previous 600 patient clinical trial.  ReGenTree is also sponsoring a Phase 3 clinical trial in patients with neurotrophic keratopathy (NK).  Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.

RGN-137, also designated an orphan drug in the U.S., is the Company's Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition causing blistering, non-healing wounds. The Company's licensee, GtreeBNT, initiated a small, open clinical trial in December 2018, in the U.S. for this indication.  The first patient treated in the trial had complete healing of the target lesion.

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.  It may also have applications in patients with severe septic shock.

For additional information about RegeneRx please visit www.regenerx.com.

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.  Forward-looking statements used in this press release relate to, among other things, research results published by third parties and the expected timing of clinical trials in the United States and abroad. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value.  There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country.  Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2018, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

Cision View original content:http://www.prnewswire.com/news-releases/regenerxs-t4-promotes-autophagy-and-repair-in-chronic-granulomatous-disease-model-300957748.html

SOURCE RegeneRx Biopharmaceuticals, Inc.