Myocardial and neurological effects of Tβ4 presented

REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) today reported on the results of several important research programs with Thymosin beta 4 (Tβ4) presented at the Second International Symposium on Thymosins in Health and Disease, in Catania, Italy. The following are synopses of the presentations:

Myocardial Effects of Tβ4

Dr. Ildiko Bock-Marquette, University of Texas, Southwestern Medical Center in Dallas, TX and her colleagues, reported that Tβ4 is “the first known molecule initiating simultaneous myocardial and vascular regeneration” in the heart after systemic administration. She went on to explain that, “efforts to use stem cells to repopulate damaged tissue are currently limited by technical consideration and restricted cell potential” and that “Tβ4 could be sufficiently utilized to inhibit myocardial cell death and stimulate vessel growth…”

Dr. Paul R. Riley, UCL Institute of Child Health in London, England, and his colleagues, who had previously reported that Tβ4 was essential for cardiac stem cell development, reported that Tβ4 also induces neovascularization (growth of new blood vessels) and tissue regeneration in the injured adult heart. According to Dr. Riley, “efficient cardiac regeneration post-myocardial infarction (MI) requires the replacement of lost cardiomyocytes, formation of new coronary blood vessels and appropriate modulation of inflammation to prevent maladaptive remodeling, fibrosis/scarring and consequent cardiac dysfunction. In the absence of extrinsic stimuli the adult mammalian heart is unable to mount an efficient reparative response following injury.” They reported that Tβ4 induced neovascularization and stimulated epicardial derived cells (cells from the heart), which facilitated survival and recovery and regenerative replacement of destroyed heart tissue, and “represents a significant step towards therapy for acute myocardial infarction (heart attack) in humans.”

Neurological Effects of Tβ4

Dr. Daniel C. Morris, Henry Ford Health Systems, Detroit, MI, and his colleagues, reported on Tβ4’s effect on functional neurological outcome in a rat model of embolic stroke (lack of oxygen to the brain caused by a blood clot). Using standardized evaluation criteria, the research team found that rats treated with Tβ4, post-stroke, demonstrated statistically significant overall improvement compared to controls. Dr. Morris stated that they observed remyelination (regeneration of the nerve sheath) of the axons and concluded that, “Tβ4 improves neurological functional outcome after embolic stroke in rats,” which is believed to be due to axonal (nerve cell fiber) remodeling.

Dermal Scarring Effects of Tβ4

Dr. Paul Ehrlich, Penn State University School of Medicine, Hershey, PA, presented new data on the effects of Tβ4 on wound healing and scarring in rat models. He found that the Tβ4-treated animal wounds were void of myofibroblasts (cells involved in wound-repair responses) and produced wounds that had regular, uniform, and organized collagen fiber bundles. According to Dr. Ehrlich, “The absence of myofibroblasts reported in other studies also show uniform organized granulation tissue collagen fiber bundles that undergo wound contraction at the same rate and are as strong as or stronger than untreated wounds enriched in myofibroblasts.” The reduction of myofibroblasts and organization of the collagen fibers resulted in scars that were significantly reduced in size and volume.

“Today’s presentations were very exciting as they further elaborated the clinical potential of our technology. There appears to be a new theme emerging having to do with tissue scarring. In several tissue sites, some of which were discussed today, reduction of scar volume (fibrosis), such as in the heart and liver, appear to correlate with better clinical outcome, while reduction in scar volume in the skin appears to allow stronger, better quality scars that could have important implications in aesthetic surgery,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer. “Dr. Morris’ data on Tβ4’s effect on regenerating neurological tissue after a stroke was similar to the first studies presented on cardioprotection and are impressive. The fact that remyelination was observed has significant implications in neurodegenerative diseases such as multiple sclerosis. We are looking forward to tomorrow’s presentations and will report on those relevant to our programs,” Mr. Finkelstein commented.

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