British Researchers Report that TB4 is Essential to Heart Development
August 02 2010 - 8:30AM
Business Wire
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the
Company” or “RegeneRx”) today announced that a research team from
the Molecular Medicine Unit at UCL-Institute of Child Health in
London reported preclinical findings that Thymosin beta 4 (Tβ4), is
essential to healthy heart development and embryonic survival.
The research was conducted by Drs. Nicola Smart, Karina Dubé and
Paul Riley, and was published online in Nature Communications; 2010 Jul 27; DIO
10.1038/ncomms1041. The research was performed under a Material
Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and
the UCL-Institute.
In the study, mice embryos were genetically modified not to
produce Hand1, a key transcription factor that plays a fundamental
role in the normal development of the heart and in congenital heart
disease. Without Hand1, Tβ4 is down-regulated, hearts are malformed
and the embryos do not survive. In this study, injection of
synthetic Tβ4 into pregnant female mice lacking Hand1 resulted in
normal development and in the survival of the early embryos. This
paper provides the first direct evidence that Tβ4 plays a critical
role in early embryonic vessel development and identifies a novel
Hand-1-Tβ4 pathway.
“These findings are important in that they establish the
molecular mechanism by which Tβ4 stimulates vascular growth of the
embryo and opens up the possibility of utilizing Tβ4 to potentially
correct serious heart defects in utero,” stated Allan Goldstein,
Ph.D., Professor of Biochemistry and Molecular Biology at The
George Washington University School of Medicine and Founder and
Chief Scientific Advisor of RegeneRx.
“We believe this research further supports development of
RGN-352, an injectable formulation of Tβ4, in acute myocardial
infarction,” said J.J. Finkelstein, Chief Executive Officer of
RegeneRx. “We plan to begin a Phase 2 study in AMI later this
year.”
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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forward-looking. Factors that may cause actual results to differ
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that our product candidates do not demonstrate safety and/or
efficacy in future clinical trials; risks related to our ability to
obtain financing to support our operations on commercially
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trials; difficulties or delays in development, testing, obtaining
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candidates; regulatory developments; the size and growth potential
of the markets for our product candidates and our ability to serve
those markets; the scope and validity of patent protection for our
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biotechnology companies; and other risks described in the Company’s
filings with the Securities and Exchange Commission (“SEC”),
including those identified in the “Risk Factors” sections of the
annual report on Form 10-K for the year ended December 31, 2009,
filed with the SEC on March 31, 2009, and the quarterly report on
Form 10-Q for the quarter ended March 31, 2010, as well as other
filings it makes with the SEC. Any forward-looking statements in
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