[September 04, 2014] |
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SCRA Technology Ventures Company Publishes Phase 2 Clinical Trial Results
CHARLESTON, S.C. --(Business Wire)--
SCRA Technology Ventures' SC Launch Portfolio Company FirstString
Research has recently completed a multicenter, randomized clinical trial
where a novel peptide has been found to heal chronic venous leg ulcers
twice as quickly as the current standard of care. FirstString's product,
Granexin™ gel, which contains the peptide, ACT1, possesses
anti-inflammatory and regenerative properties. The results of this Phase
2 study, investigating the efficacy and safety of this topical ACT1
formulation when combined with standard care in treatment of chronic
venous leg ulcers, were recently published in the prestigious Journal
of Investigative Dermatology. The study findings have been released
and will be available in print in the upcoming issue.
FirstString Research, a Charleston-based clinical stage biotech company,
focuses on the development and commercialization of therapeutics for
scar prevention and tissue regeneration. ACT1 is synthetic peptide
modeled after a portion of the intercellular communicating protein
connexin43, and works by targeting connexin43's binding partners and
modulating intercellular communication and cell-to-cell contact.
Venous leg ulcers develop as a result of impaired circulation in the
legs leading to venous hypertension and vessel damage. The tissues break
down from the inside out resulting in ulcer formation. It is a
particular problem in the elderly and can lead to painful wounds that
remain refractory to current treatments that often recur even after
closure. In most people, such an injury heals without difficulty within
a week or two. However, when there is an underlying problem the skin
does not heal and the area of breakdown can increase in size resulting
in a chronic ulcer and the need for specialized care.
"Chronic wounds, like venous leg ulcers, remain stalled in the initial
inflammatory phase of wound healing and fail to heal. What is broadly
lacking, are therapeutics that address the underlying pathophysiology
associated with the impaired wound healing response in these wounds. "
said Dr. Christina Grek, Director of Translaional Research at
FirstString.
The clinical trial included participants with chronic ulcers that had
remained refractory to standard of care for an average of 17 months. At
12 weeks, GranexinTM treatment was associated with a 43%
increase in incidence of complete ulcer closure as compared to control
treatment alone. This translates to a significant improvement in terms
of healing prognosis. GraenxinTM was also safe and
well-tolerated.
"ACT1 represents a first-in-class drug that targets the connexin
signaling pathways. This publication denotes the first peer-reviewed
report of a randomized, multi-center, controlled, clinical trial
demonstrating connexins as effective biological targets for wound
healing." said Dr. Gautam Ghatnekar, CEO of FirstString. "This
represents a milestone for FirstString Research, and I am proud of our
team for a great job on executing the Phase 2 clinical trial in venous
leg ulcer patients."
"We are pleased that FirstString has successfully completed this Phase 2
study and will receive recognition in a respected publication," said
SCRA CEO Bill Mahoney. "FirstString continues to make strides in the
wound healing technology market and we are delighted that this
significant technology company calls South Carolina home."
FirstString Research is now planning Phase 3 trials for FDA approval of
GranexinTM gel, for use in venous leg ulcers patients.
About SCRA
http://www.scra.org/
SCRA Technology Ventures helps innovative companies grow and develop new
technologies, creating jobs and advancing the Knowledge Economy
throughout South Carolina. This SCRA business sector provides support
and mentoring to early stage, start-up technology companies through its
flagship SC Launch. Since 2006, SCRA has deployed over $81 million in
funding for entrepreneurs and infrastructure to support over 290
high-tech, early-stage enterprises. SCRA has directly invested over $19
million into the program's top 71 South Carolina start-ups, attracting
over $301 million in add-on private investment. SCRA Technology Ventures
also supports commercialization and growth by facilitating the transfer
of intellectual property and accelerating the transition of inventions
to the marketplace.
Multiple economic impact studies show SCRA's cumulative output on South
Carolina's economy to be over $16.6 billion, and that the company has
helped create approximately 15,000 technology-related jobs in the state,
with annual wages averaging between $55,000 and $77,000.
About FirstString Research
www.firststringresearch.com
FirstString Research, a privately held clinical stage biotech company,
is leading the translation of cell-cell communication and cell-cell
contact/adhesion science into a pipeline of drugs and medical
applications for wound healing, scar reduction, inflammation, and
complex tissue regeneration. The company is currently advancing GranexinTM
gel, a topical formulation containing the ACT1 peptide, for the
treatment of chronic wounds and scar reduction, through clinical trials,
with the goal to broaden the treatment options for patients suffering
from morbidities associated with acute and chronic wounds. FirstString
is also conducting preclinical studies with ACT1 for additional
indications having high unmet therapeutic needs in a number of
therapeutic segments that include ophthalmology, CNS injuries, cardiac
injuries, organ transplants, acute lung injuries, and oncology.
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