2004-11-24 13:00:05
Researchers Report Wound Healing Drug Significantly Reduces Cardiac Damage After Heart Attack; New Studies With RegeneRx's TB4 Detailed in Nature Article

Business Editors / Biotech Writers

BETHESDA, Md.--(BUSINESS WIRE)--Nov. 24, 2004--
Researchers at the University of Texas Southwestern
Medical Center report in the November 25th issue of Nature that
Thymosin beta 4 (TB4), a naturally occurring peptide being developed
by RegeneRx Biopharmaceuticals, significantly reduced tissue damage,
ventricular scarring and dilation, and markedly improved cardiac
function when administered to laboratory animals immediately following
induced myocardial infarction (heart attack). Heart attacks occur in
over one million people annually in the United States with over
thirteen million suffering from coronary artery disease, making it the
single largest cause of death in the Western world.
Dr. Deepak Srivastava, the head of the research team and a
professor specializing in pediatric cardiology, stated that, "While we
do not know exactly how TB4 is preventing or reducing damage to the
heart, the evidence suggests that it may prevent apoptosis (natural
cell death) resulting from a cardiac infarction. TB4 may also be
protecting the cardiac cells from dying by causing them to 'hibernate'
and withstand hypoxia (lack of oxygen) caused by a heart attack."
"The effects appear similar to those reported in dermal and ocular
wound healing studies using TB4, especially at the cellular level, but
it is remarkable that it has such an effect on a whole organ," said
Dr. Srivastava. He added that future experiments will be conducted in
pigs, whose hearts most resemble humans.
According to Dr. Alan Wasserman, a noted cardiologist and
Professor and Chairman of the Department of Medicine at The George
Washington University School of Medicine in Washington, D.C., "This
paper by Dr. Srivastava and colleagues is one of the most exciting
works in the field of acute myocardial infarction I have seen. The
ability to repair (cardiac) muscle after an acute infarction makes the
use of TB4, potentially, the most important discovery since the advent
of thrombolytic therapy."
Dr. Srivastava and his colleagues in the departments of
pediatrics, molecular biology and cardiothoracic surgery administered
TB4 two ways: by direct injection into the heart muscle and by
systemic injection. The effects from both methods were similar and
results from both were significantly better than the control group.

The researchers also reported on the results of several in vitro
experiments:

-- TB4 administered to cardiac cells in vitro caused the cells to
beat more rhythmically, more rapidly, more vigorously and
twice as long vs. the control group.

-- The addition of TB4 onto a collagen-coated gel assay caused a
large number of spontaneously beating, cardiac muscle cells to
migrate in more numbers and further distances than control
cells.

-- TB4 was expressed in specific regions of the developing heart
that were undergoing active cell migration.

"To my knowledge, there has never been a report of any agent able
to affect cardiac cells in these ways. That we have been able to
observe such results opens up a potential new approach for treating
heart attack victims," concluded Dr. Srivastava.

RegeneRx Biopharmaceuticals, Inc.

RegeneRx (OTCBB:RGRX, www.regenerx.com) is a biopharmaceutical
company developing TB4 as a platform technology for the treatment of
acute and chronic wounds and for the treatment of a variety of human
diseases involving tissue and organ repair under an exclusive
world-wide license from the National Institutes of Health. The
technology is also the subject of over forty world-wide patents and
patent applications held by RegeneRx related to dermal, ocular, and
internal wounds and tissue repair, including the treatment and
prevention of cardiac injury. RegeneRx successfully completed a Phase
I human clinical trial with TB4 for the treatment of chronic dermal
wounds and has recently received clearance from the U.S. FDA to
conduct the first in a series of Phase II dermal trials, according to
J.J. Finkelstein, RegeneRx's President and CEO.

Thymosin Beta 4

TB4 is a naturally occurring peptide present in virtually all
human cells. It represents a new class of wound healing drug and is
different from other wound repair factors, such as growth factors, in
that it promotes endothelial cell differentiation and keratinocyte
cell migration, and down-regulates a number of inflammatory cytokines
and chemokines. A key mechanism of action is TB4's ability to regulate
the cell-building protein, actin, a vital component of the
cytoskeleton. Additionally, it has recently been reported that TB4
directly influences the production of laminin-5, a protein necessary
for proper adhesion of certain types of mammalian cells and an
important component of the wound healing process. It has also recently
been reported that TB4 can inhibit or prevent apoptosis (programmed
cell death) in ocular tissues. Researchers at the National Institutes
of Health (NIH), and at other academic institutions throughout the
U.S., have published numerous scientific articles indicating that TB4
is effective in accelerating dermal and corneal wounds in several
animal models, under a variety of conditions.

UT Southwestern Medical Center / Dr. Deepak Srivastava

Part of The University of Texas System, UT Southwestern is located
in Dallas, Texas and includes three degree-granting institutions:
Southwestern Medical School, Southwestern Graduate School of
Biomedical Sciences, and Southwestern Allied Health Sciences School.
These schools train approximately 3,520 medical, graduate and allied
health students, residents and postdoctoral fellows each year. As one
of the foremost research facilities in the world, UT Southwestern has
four active Nobel Laureates and 15 members of the prestigious National
Academy of Sciences on its faculty and conducts more than 2,000
research projects annually totaling more than $298 million. The
medical center provides inpatient care to more than 87,000 people and
oversees approximately 2 million outpatient visits annually.
Deepak Srivastava, M.D., is Associate Professor holding both the
Pogue Distinguished Chair in Research on Cardiac Birth Defects and the
Joel B. Steinberg, M.D., Chair in Pediatrics. His research is
primarily focused on congenital abnormalities of the pediatric heart,
in particular, genetic and biomedical influence on cardiac
development. Through his expertise in developmental biology, molecular
biology and human genetics, his goal is to understand organogenesis
and the mechanisms underlying congenital malformations.

The information in this press release may include certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements concern the
Company's current expectations regarding future events, including the
ongoing and prospective development of TB4 and possible future
benefits to the Company, its shareholders, and patients. Due to the
nature of product development and the regulatory approval process, the
forward-looking statements are subject to risks and uncertainties,
including those reflected in the Company's filings with the Securities
and Exchange Commission, particularly its most recent Annual Report on
Form 10-KSB. The Company assumes no obligation to update or revise any
forward-looking statements made herein or any other forward-looking
statements made by the Company.

KEYWORD: NORTH AMERICA DISTRICT OF COLUMBIA MARYLAND TEXAS UNITED STATES
INDUSTRY KEYWORD: HEALTH ALTERNATIVE MEDICINE BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS GENETICS PHARMACEUTICAL RESEARCH & SCIENCE PRODUCT/SERVICE
SOURCE: RegeneRx Biopharmaceuticals, Inc.

CONTACT INFORMATION:
RegeneRx Biopharmaceuticals, Inc.
J.J. Finkelsten, 301-961-1992
jjfnk@regenerx.com
or
Financial Relations Board:
Media Inquiries:
Tim Grace, 312-640-6667
or
Investor Inquiries:
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General Inquiries:
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