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Charleston, SC, United States

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 232.76K | Year: 2012

DESCRIPTION (provided by applicant): According to the World Health Organization, at least 171 million people worldwide are living with diabetes and this figure is likely to more than double by the year 2030. Because of its chronic nature, the severity of its complications and the means required to control them, the economic burden is enormous not only to the individuals and families involved but also to the health system. Wound healing in diabetics, in general, is severely impaired, which has a great impacton the economic and social burden of our society. Diabetes is the leading cause of new cases of blindness among adults aged 20-74 years. Although retinopathy is the primary cause of blindness in these patients, in the past 3 decades it has been noted that47-64% of diabetic patients will manifest diabetic keratopathy or other corneal abnormalities, which are potentially sight threatening. Currently, therapies to treat these corneal epithelial wounds are very limited. FirstString Research, Inc is an early stage biotech company developing therapeutic peptides for applications in tissue engineering and regenerative medicine. FirstString's lead novel bioengineered peptide dubbed ACT1, is based on the C-terminal sequence of connexin 43 (Cx43), and shows great promise in modulating intercellular communication. ACT1 works by stabilizing gap junctions and maintaining intercellular communication between cells that is essential for wound repair or injury response. Preliminary data from our company has indicated that this peptide can effect accelerated wound healing, reduce inflammatory response, reduce scar formation and restore skin structure following acute injury in a diabetic mouse model system. Furthermore, ACT1 peptide has been shown to promote corneal wound closure following ethanol burn injuries to the rat cornea, compared with that of a control peptide. Based on these early findings we hypothesize that ACT1 peptide will increase corneal re-epithelialization and accelerate wound closure following injury to the corneas of diabetic rats as demonstrated by the aims outlined in this Phase I SBIR application. The completion of aims outlined in this project will set the stage for a future Phase II SBIR and could lead to a commercially viable therapeutic in the clinicalmanagement of diabetic keratopathy. PUBLIC HEALTH RELEVANCE: According to the World Health Organization, at least 171 million people worldwide are living with diabetes. Corneal disorders secondary to diabetes, such as diabetic keratopathy, are an increasing cause of morbidity associated with diabetes and affects 47-64% of diabetics during the course of their disease. Conventional therapies for the treatment of these corneal wounds have failed. FirstString Research Inc. has developed a novel therapeutic peptide that may promote re-epithelialization of the cornea, reduce scarring and inflammation and thereby prevent potential blindness in diabetics with such disorders.

Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 99.86K | Year: 2015

Ocular traumas resulting from explosive or incendiary devices are one of the most common injuries reported by our armed forces. Current standard of care protocols do not address the biological and molecular processes in corneal wound healing, and therapeutic failure is associated with corneal ulcers, scarring, and loss of vision. Ocular therapeutics that have regenerative healing properties, restore corneal biomechanical integrity and can be readily applied in the field will greatly enhance therapeutic outcome. FirstString Research has developed an ophthalmic eye-drop formulation containing the short regulatory peptide (ACT1) that possesses anti-inflammatory properties and enhances corneal regeneration via the stabilization of gap and tight junctions by modulating junctional protein interactions. The proposed Phase I SBIR will test the hypothesis that an ophthalmic ACT1 peptide formulation can accelerate corneal reepithelialization and restore corneal biomechanics, thus improving visual outcome. Using pre-clinical corneal injury models of blast and burn, our goal is to evaluate the therapeutic potential of an ACT1 ophthalmic formulation with respect to corneal and lentricular pharmacokinetics, corneal regeneration, corneal scarring, and corneal biomechanics. Successful completion of this study will demonstrate feasibility and will allow us to perform comprehensive translational technology development in a future Phase II effort.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2015

DESCRIPTION provided by applicant Glioblastoma GBM is an incurable cancer even with aggressive therapies such as surgical resection followed by radiotherapy and chemotherapy using temozolomide TMZ Efforts to improve surgical resection or the efficacy of irradiation are limited by the potential damage these interventions cause to the brain In contrast sensitizing GBM to TMZ is an appealing strategy because TMZ has excellent brain penetration and a low toxicity profile Recent research has suggested that targeting the gap junction protein connexin Cx holds promise for enhancing TMZ sensitivity in GBM Dr Gourdieandapos s co Investigator laboratory has developed a synthetic peptide ACT which comprises the carboxy terminus of Cx and has demonstrated therapeutic effects in promoting healing of chronic wounds FirstString Research has licensed ACT for further development and clinical application and has advanced Granexin tm Gel the topical formulation of ACT peptide through three successfully completed Phase human clinical trials for scar reduction and the treatment of chronic wounds In collaboration with the Shengandapos s co Investigator laboratory we observed that Cx expression inversely correlates to TMZ sensitivity and GBM patient survival and demonstrated that ACT significantly increases TMZ sensitivity in vitro and in vivo thus encouraging us to further investigate its therapeutic potential in sensitizing GBM tumors to TMZ However intracranial delivery of this peptide is limited by its relatively short half life Therefre the overall objective of this application is to develop a novel delivery approach for ACT to treat GBM in vivo The use of biodegradable nanoparticles for peptide delivery is a powerful approach due to its high biocompatibility and sustained peptide release The rationale of this study is that ACT loaded nanoparticles ACT NP will efficiently deliver ACT into the brain by constantly and continuously supply GBM tumor cells with this peptide Our hypothesis is that ACT NP will sensitize GBM to TMZ which will then be tested in two specific aims to engineer ACT NP and optimize controlled delivery of ACT in vitro to assess in vivo the therapeutic potential of ACT NP in tandem with TMZ treatment of brain tumors We will first generate ACT NP in collaboration with Dr Foster co Investigator and his laboratory using poly lactic co glycolic acid PLGA copolymer After in vitro characterization of ACT NP and effect on human GBM cells we will intracranially inject ACT NP into the brains of GBM mice followed by TMZ treatment We will monitor the tumor growth using magnetic resonance imaging and analyze mice survival These results will validate the therapeutic effect of ACT in vivo We expect that this approach will efficiently deliver ACT in a sustained way and sensitize GBM tumors to TMZ The proposed research is significant because this innovative approach will not only allow us to develop novel combinational therapies for lethal GBM but also will lay foundation on potential clinical trials in newly diagnosed GBM patients in the near future Finally our new ACT NP may be scalable to other CNS diseases that could benefit from Cx targeting PUBLIC HEALTH RELEVANCE Glioblastoma is a very aggressive type of brain tumor and one of the most deadly diseases with no efficient therapy to cure it The proposed research aims at developing a new combinational therapy to enhance the effectiveness of temozolomide the front line chemotherapy for glioblastoma Therefore this work will have important impact on therapeutic intervention for glioblastoma and is relevant to public health and NIHandapos s mission

Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 173.80K | Year: 2012

This Small Business Innovation Research (SBIR) Phase I project is a feasibility assessment of the ocular delivery of a synthetic peptide, ACT1, for the treatment of Age-Related Macular Degeneration (AMD). AMD is a retinal disease in patients who progressively lose their central vision through pathological and damaging conditions of the macula primarily by the development of leaky blood vessels in the retina of the eye. The objective is to determine whether ACT1 can be transported passively to the retinal epithelial cell layer, elicit a response consistently on blood vessel lesions of the macula, and slow the progression or restore visual functions in vivo as a milestone for the further development of a topical eye drop formulation.

The broader/commercial impacts of this research are manifold and foremost the potential commercialization of a much needed treatment option for patients suffering from AMD. AMD affects approximately 25 to 30 million people worldwide and is the leading cause of vision loss for Americans 60 years old or older, with close to 2 million people suffering in the United States. Current treatments of AMD require the use of drugs are administered chronically to patients by injections into the eyes that can be quite painful as well as eliciting further safety concerns, and are modestly effective in slowing the rate of vision loss. A topically delivered therapeutic may provide a variety of benefits including easier, faster, and cheaper treatments of patients, patient self-care, and potentially jumpstart a new industry for the optometric management of AMD.

News Article | June 24, 2015
Site: www.businesswire.com

SUMMERVILLE, S.C.--(BUSINESS WIRE)--SCRA Technology Ventures’ SC Launch Board recently finalized investments for two Charleston, S.C.-based companies. Charleston Pharma, who received board approval for investment in May 2015, and FirstString Research, who received board approval in March 2015 have now received funds from the program. Both companies will utilize the investment to expanded operations. Charleston Pharma is focused on developing innovative therapeutic antibodies and related diagnostic tests for cancer patients and healthcare providers. Research is done in laboratories at the SCRA MUSC Innovation Center and is designed to identify the most promising antibodies for studies that will establish preclinical efficacy and safety. Part of the SC Launch program since October 2010, Charleston Pharma has received a grant and two rounds of investment from the program. The most recent investment will be used to expand recombinant production efforts, explore antibody-drug conjugates and add animal efficacy studies. FirstString Research, an SC Launch company since 2006, is a privately held, clinical-stage biotechnology company that focuses on scar prevention, inflammation reduction, wound healing and complex tissue regeneration. This investment will be the fourth round of SC Launch funding for the company. “It is through the continued support and development of innovative companies like these that we are seeing the high-tech economy in South Carolina continue to grow,” said SCRA CEO Bill Mahoney. “We are delighted to support these companies and the great work they are doing in South Carolina.” SCRA Technology Ventures enables research commercialization and promotes the development of high tech industries, enhancing South Carolina’s technology-based economy. Through its flagship SC Launch program, this SCRA business sector makes investments in and offers support services to South Carolina’s early stage, start-up technology companies. Multiple economic impact studies show SCRA's cumulative output on South Carolina's economy to be over $18.1 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 $79,000.

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