Researchers Report in Neuroscience that TB4 Improves Neurological Function after Stroke
July 19 2010 - 11:30AM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the
Company” or “RegeneRx”) today announced a research team from the
Henry Ford Hospital in Detroit, MI, reported that Thymosin beta 4
(Tβ4), administered to rats after embolic stroke, improved
neurological functional outcome compared to control animals.
The research was conducted by Dr. Daniel Morris and his
colleagues at the Department of Emergency Medicine, Henry Ford
Health System, Detroit, MI, and published in Neuroscience, 2010 Aug 25 169(2) 674-682,
http://www.ncbi.nlm.nih.gov/pubmed/20627173. The research was
performed under a Material Transfer Agreement between RegeneRx
Biopharmaceuticals, Inc. and the Henry Ford Health System.
Improvement in neurological function was measured at various
time intervals over a seven week period and was statistically
significant. A statistically significant increase in remyelination
of axons and vessel density in the ischemic boundary was also
observed between rats receiving Tβ4 vs. controls, likely due to an
increased mobilization of oligodendrocyte progenitor cells (brain
stem cells that differentiate into cells that protect nerve
fibers). mRNA levels for the epidermal growth factor receptor were
determined in both normal and stroke rats treated with Tβ4 and were
approximately 50% higher in the stroke-treated rats. This receptor
has previously been shown to be a key regulator of progenitor cell
expansion and tissue regeneration in response to brain injury and
further confirms the role of Tβ4 in stem cell-mediated tissue
repair.
“Some of these data were previously reported at an International
Stroke Conference in March; however, the data published today
include more specific information on functional remodeling and
potential mechanisms of action related to recruitment and
differentiation of oligodendrocyte progenitor cells. These data are
compelling and elaborate previously reported data in EAE mice
(experimental models for multiple sclerosis) and in traumatic brain
injury in rats showing that Tβ4 can effect regeneration of neuronal
cells after injury. In this experiment, after an ischemic stroke,
neurological function in the rat models was significantly improved,
apparently by remyelination of neurological axons (nerve fibers
that conduct electrical signals) induced by Tβ4. The fact that Tβ4
helps repair and regenerate tissue after a brain injury strongly
correlates with other published data showing Tβ4’s ability to
regenerate neuronal and cardiac tissue after ischemic events,”
stated Dr. Hynda Kleinman, former head of cell biology at the
National Institute of Dental and Craniofacial Research, NIH, and a
consultant to RegeneRx.
About Tβ4
Tβ4 is a synthetic version of a naturally occurring peptide
present in virtually all human cells. It is a first-in-class
multi-functional molecule that has been shown in pre-clinical
studies to promote endothelial cell differentiation and migration
in the heart and central nervous system, promote angiogenesis in
dermal and cardiac tissues, increase keratinocyte migration and
collagen deposition, and decrease inflammation by down-regulating
inflammatory cytokines. RegeneRx has identified several molecular
variations of Tβ4 that may affect the aging of skin, among other
properties, and could be important candidates as active ingredients
in pharmaceutical and consumer products. Researchers at the
National Institutes of Health and various academic researchers
throughout the world have published numerous scientific articles in
high impact journals indicating Tβ4’s in vitro and in vivo efficacy
in accelerating wound healing and tissue protection and
regeneration under a variety of conditions. Abstracts of scientific
papers related to Tβ4’s mechanisms of action can be viewed at
www.regenerx.com.
About RegeneRx
Biopharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic
peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection,
repair and regeneration. Currently RegeneRx has three products
in clinical development. RGN-352 is an injectable formulation to
treat cardiovascular and central nervous system diseases, as well
as other medical indications. RegeneRx has successfully completed a
Phase 1 clinical trial with RGN-352. RGN-259 is a sterile,
preservative-free topical eye drop for ophthalmic indications.
RegeneRx is currently supporting a physician-sponsored Phase 2 dry
eye study evaluating RGN-259. RGN-137, a topical gel formulation,
is currently being evaluated by RegeneRx in a Phase 2 clinical
trial for the treatment of epidermolysis bullosa. Other potential
uses for RGN-137 include the treatment of chronic dermal wounds and
reduction of scar tissue. Based on strong efficacy data in
pre-clinical studies, RegeneRx is initially targeting RGN-352 for
the treatment of patients who have suffered an acute myocardial
infarction, or heart attack. In addition to this indication, recent
pre-clinical efficacy data suggests that RGN-352 may also benefit
patients with multiple sclerosis and stroke. RegeneRx also has a
preclinical product candidate, RGN-457, which is an inhaled
formulation targeting cystic fibrosis and other pulmonary diseases.
In addition to the four pharmaceutical product candidates described
above, RegeneRx is pursuing the commercial development of peptide
fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds 75
issued patents and has 261 patent applications pending worldwide
related to its products and holds an exclusive worldwide license
for Tβ4 from the National Institutes of Health.
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