Claremont, CA, United States
Claremont, CA, United States

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The present invention is directed to chitosan-derivative compounds and structures, methods of making chitosan-derivative compounds and methods for controlling, inhibiting and enhancing microbial populations in a variety of environments. The present invention is also directed to the control, inhibition and enhancement of microbial populations in animals, particularly humans. The microbial populations include bacteria, viruses and other pathogens where control of microbial populations are a necessity. The chitosan-derivative compounds of the present invention include chitosan-arginine compounds, related chitosan-L/D unnatural amino acid compounds, chitosan-acid amine compounds, chitosan-L/D natural amino acid derivative compounds, co-derivatives of the chitosan-derivative compounds, salts of the chitosan derivative compounds, and chitosan-guanidine compounds.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 149.90K | Year: 2013

Thermal injury is common in military conflicts due to primarily to the widespread use of explosive devices. Burns can produce scars that are excessive, physically debilitating and functionally damaging. There is a critical need for an effective product that can control bacterial contamination and prevent colonization, mitigate inflammation, and diffuse to or reach necrotic and damaged tissue resulting from a blast or traumatic thermal wound to reduce the formation of fibrotic scars. Synedgen has developed a biocompatible polysaccharide derivative (PAAG) that has been demonstrated in vivo and in vitro to reduce inflammation and provide enhanced healing with the reduction of scarring. This Phase 1 study will demonstrate the extent to which PAAG mitigates scar reduction in full thickness burns in a porcine model, and provide an opportunity to examine innate immune responses, inflammatory cytokines and healing pathways.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 870.53K | Year: 2014

Thermal injury is common in military conflicts due primarily to the widespread use of explosive devices. Though scar formation is a natural process of wound healing, burns can produce scars that are excessive, physically debilitating and functionally damaging. Synedgen has demonstrated the efficacy of a safe topical treatment to reduce inflammation, prevent infection in, improve the healing rate of and reduce the magnitude of scar formation in burns. Synedgen uses a derivative of a natural biopolymer to prevent the initial stages of inflammation due to damage and necrotic tissue. Consequently, the burn healing process shifts to a regenerative phase earlier and is stimulated to heal, without the complications of unmitigated inflammation. This product can be used alone or in combination with other products to provide better management of burn wounds. This Phase II proposal will accelerate the development of this product into the clinic by completing studies of preclinical efficacy in animal models, complete the molecular validation of the polymer active ingredient and provide detailed steps and timelines for bringing this product to clinical trials.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 146.41K | Year: 2015

DESCRIPTION provided by applicant Cystic fibrosis CF is a genetic disease resulting from a variety of defects of the cystic fibrosis transmembrane conductance regulator CFTR gene that is involved in the transport of chloride and bicarbonate ions across the cell membrane CF mostly affects the lungs intestines and pancreas The progression of the CF disease is most commonly associated with decline in pulmonary function however the CFTR also affects electrolyte transport in many organs including the GI tract resulting in pancreatic insufficiency nutritional malabsorption and significant reductions in gastrointestinal GI motility altering te fecal microbiota In the GI tract the reduction or loss of CFTR function results in abnormal electrolyte composition and dehydration of the lumen resulting in thick adherent mucus and reduced GI motility as also observed in the lungs Consequently meconium ileus is observed in of CF newborns and causes significant morbidity including large resections of bowel that cause permanent disability Distal intestinal obstructive syndrome DIOS formerly called meconium ileus MI equivalent causes similar events in older children and adults and is associated with severe morbidity and prolonged hospitalizations Current treatments are non specific and similar to that used for the non CF population but with greatly increased intensity this includes osmotic stool softeners and supplementation with stimulant laxatives but do not address the underlying cause of mucus and stool obstruction Currently no current treatments are intended to address the underlying adhesive properties of CF mucus that cause impacted mucus stool and associated inflammation representing a significant unmet medical need This proposal tests a novel orally administered polysaccharide therapeutic with demonstrated pulmonary mucolytic activity and anti inflammatory GI action to treat CF obstructive disorders and associated intrinsic inflammation Both prophylaxis and treatment of GI obstruction will be tested in rat models Biomarkers of inflammation and GI damage will be assessed along with gene expression changes in the ileum and jejunum associated with treatment in order to better understand mechanisms of action This proof of principle study will be used to determine the efficacy of this new therapeutic and its potential for advancement as a drug candidate PUBLIC HEALTH RELEVANCE Cystic fibrosis CF is a genetic disease resulting defects of the cystic fibrosis transmembrane conductance regulator CFTR gene that is involved in the transport of chloride and bicarbonate ions across the cell membrane In the GI tract the reduction or loss of CFTR function results in abnormal electrolyte composition and dehydration of the lumen resulting in thick adherent mucus and reduced GI motility meconium ileus distal intestinal obstructive syndrome DIOS and is associated with severe morbidity and prolonged hospitalizations This proposal tests a novel orally administered polysaccharide therapeutic with demonstrated pulmonary mucolytic activity and anti inflammatory GI action to treat CF obstructive disorders and associated intrinsic inflammation in animal models


Patent
Synedgen | Date: 2014-03-14

Described herein are a solution, composition, and kit of poly (acetyl, arginyl) glucosamine (PAAG), methods of making the solution, and method of treating wounds with the solution, the method comprising administering to a subject an effective amount of a solution comprising PAAG, wherein the PAAG when administered topically contacts the wound, thereby treating the wound.


Described herein are methods and compositions that contain a soluble polyglucosamine or polyglucosamine derivative for use in oral health. The compositions are useful for, e.g., reducing bacteria (e.g., by clumping and removing) or disrupting a biofilm in the mouth of a subject, reducing dry mouth, and reducing oral inflammation.


The present invention is directed to chitosan-derivative compounds and structures, methods of making chitosan-derivative compounds and methods for controlling, inhibiting and enhancing microbial populations in a variety of environments. The present invention is also directed to the control, inhibition and enhancement of microbial populations in animals, particularly humans. The microbial populations include bacteria, viruses and other pathogens where control of microbial populations are a necessity. The chitosan-derivative compounds of the present invention include chitosan-arginine compounds, related chitosan-L/D unnatural amino acid compounds, chitosan-acid amine compounds, chitosan-L/D natural amino acid derivative compounds, co-derivatives of the chitosan-derivative compounds, salts of the chitosan derivative compounds, and chitosan-guanidine compounds.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 196.71K | Year: 2014

Radiotherapy is a well-established treatment for cancer, however pelvic radiotherapy can result in radiation proctitis, particularly after treatment of prostate or cervical cancer. In severe cases, radiation proctitis can result in the need to reduce the intensity of radiotherapy, ultimately jeopardizing the patient's prognosis for successful cancer treatment. Synedgen has developed treatments using a proprietary polymer, PAAG, to reduce radiation or chemical damage to mucosal surfaces, with particularly potent radio-mitigation activity in the gastrointestinal tract. Synedgen's non-systemic oral or enema treatments have been demonstrated to reduce local and systemic inflammation, reduce cell death and improve tissue regeneration associated with radiation-induced damage in the large and small intestines and the duodenum. The results of this proposal will demonstrate proof-of-principle efficacy for Synedgen's PAAG radiation mitigation in radiation proctitis, for radiotherapy where the tumor is distal from the mucosal surface. Plans will be developed to assess any effects of the PAAG treatment on altering tumor response to radiation. Finally, hypothesis-driven gene array assessments of PAAG-affected molecular pathways leading to the observed therapeutic mechanismwill be completed. The goal is to advance a novel radiation mitigation therapy to improve patient morbidity and to allow for complete or more aggressive treatment of prostate and other cancers that are limited by radiation proctitis. PUBLIC HEALTH RELEVANCE


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.41K | Year: 2016

DESCRIPTION provided by applicant Crohnandapos s disease is an inflammatory disorder of the gastrointestinal GI tract likely associated with a hyperactive immune response to commensal bacteria and mucosal damage The treatments for Crohnandapos s disease and inflammatory bowel diseases IBDs in general have the potential for serious side effects New approaches for controlling the progression of these diseases are needed A treatment that works at the mucosal surface to modulate mucosal inflammation and associated GI damage to prevent or reduce disease severity would change the quality of life for millions worldwide A recently developed polysaccharide derivative PAAG acts at the mucosal surfaces to facilitate a reduction of inflammation and enhanced barrier function by reducing GI damage Understanding how PAAG directly modulates key mediators in innate host defense and mucosal integrity such as toll like receptors TLRandapos s and similar pathways is essential in providing a well tolerated treatment alternative In vitro cell based assays will assess the influence of PAAG on TLR activation by pathogen associated molecular patterns PAMPandapos s and damage associated molecular patterns DAMPandapos s in human GI cells via colorometric signal transduction reporter gene based assays and pathways focused qPCR analysis The effectiveness of oral PAAG treatment in the adoptive transfer model of chronic colitis in vivo will be assessed and compared to confirm prior study success in acute GI inflammatory animal models Genes influencing the therapeutic response of PAAG in the mouse colon compared to vehicle control will be identified following hypotheses driven gene expression analysis guided by prior gene expression analysis in related models of GI inflammation Fecal and serum markers indicative of the level of GI damage and inflammation will be measured via ELISA and further validate the effectiveness of PAAG treatment Molecular methods will determine if microbiome diversity is influenced by treatment with PAAG The goal of this study is to optimize PAAG dosage and elucidate specific mechanisms that facilitate efficacious disease treatment Successful outcomes will guide further development of this product toward clinical trials of a safe and effective treatment for Crohnandapos s disease and related IBDandapos s PUBLIC HEALTH RELEVANCE Crohnandapos s disease is a specific form of debilitating inflammatory bowel disease IBD caused by a dysregulated intestinal immune response associated with a breakdown in the intestinal mucosal barrier and homeostasis An estimated million people in the US suffer from Crohnandapos s disease and a related disease of the colon ulcerative colitis Many currently available therapies have significant side effects and little chance of a cure The development of a novel treatment PAAG by Synedgen is expected to treat Crohnandapos s disease and related IBDandapos s by working directly at the mucosal surface to modulate dysregulated inflammation and enhance barrier function with the potential to improve the quality of life for millions of people worldwide


Described herein is a method of reducing bacteria in the mouth of a subject, the method comprising contacting (e.g., rinsing) the mouth with an effective amount of a composition comprising a soluble derivatized chitosan, thereby reducing bacteria in the mouth of the subject.

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