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SCRA Technology Ventures Company Publishes Phase 2 Clinical Trial Results
[September 04, 2014]

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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