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MUSC spin-off firm to test
by Heather Woolwine
First-String Research Inc. (FSR), an MUSC spin-off biotechnology
company, has begun human testing a unique, wound-healing peptide gel
that could help patients with diabetes and other conditions that
inhibit tissue regeneration.
Already past the preliminary approval stages, the first human trial is
being conducted in Switzerland. Initial preclinical studies have
suggested the gel’s efficacy and safety in regenerating new tissue,
instead of creating scar tissue, to heal wounds better and faster than
any product currently on the market.
In the clinical trial, four different doses of the gel will be
administered to study participants with deep wounds. Those wounds will
be examined periodically, and positive results from the study could put
FSR’s wound-healing gel one step closer to Food and Drug Administration
(FDA) approval. Currently, no mechanistically-based products that can
reduce or eliminate scarring and promote wound regeneration have been
approved by the FDA.
“We have received an enormous amount of positive feedback from the
investment community at large, including industry experts who were
astonished at what we were able to achieve with such little funding,”
said Gautam Ghatnekar, Ph.D., FSR president and gel-peptide
co-inventor. “This product truly marks a paradigm shift from healing
with a disfiguring scar to encouraging normal tissue regeneration.”
The original peptide was created in the lab of Robert Gourdie, Ph.D.,
MUSC professor of cell biology and Clemson professor of bioengineering.
Now an FSR board member, Gourdie is encouraged by the potential of the
peptide he created andthe gel technology he co-invented with Ghatnekar.
“This peptide has tremen-dous potential in all body situations that
involve healing, because it regulates and modifies intercellular
communication at the site of the wound,” Gourdie said.
The company that began a few years ago has received positive feedback
from the investment community concerning its product. Recently, FSR was
chosen as one of four finalists among 40 companies that competed for
the chance to present their work to the investment community across the
Southeast during the Southeast Biotechnology Forum (SEBIO).
“SEBIO is the premier venue in the Southeast for young life sciences
companies to test their marketability, and as such, we are privileged
to have been selected as a finalist,” said FSR CEO Spencer Robert. “We
went through multiple review processes, each conducted by a mixture of
successful entrepreneurs, venture capitalists and other industry
experts. The publicity and interest we received from the event was
invaluable. Our secret is definitely out.”
Additionally, FSR is collaborating with MUSC on a National Institutes
of Health-National Institute of Diabetic Digestive Kidney Diseases
grant to study the peptide in treating diabetic wounds. The two
entities also are working together to examine the peptide’s efficacy in
treating spinal cord injuries. This work is in the preliminary stages
and has not yet progressed to clinical trials, FSR officials said.
Meanwhile, the Office of Naval Research has expressed interest in FSR’s
technology, which may be used to develop projects to see how the
peptides could be used to treat injured soldiers on the battlefield.
How it works
The skin’s wound-repair process is initiated immediately after injury
and involves inflammation, cell proliferation, scar production, and
tissue remodeling. One of the common complications in wound healing is
excessive scarring. Gourdie and Ghatnekar developed the bioengineered
peptide based on a naturally-occurring protein in the body that helps
regulate communication between cells. This peptide accelerated wound
healing and tissue regeneration with significantly reduced scarring in
laboratory animal tests, and has led researchers to believe that it
will promote faster healing, reduced scarring, and restoration of more
normal looking skin during human clinical trials.
Friday, Feb. 8, 2008
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