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Antimicrobial and Regenerative Treatment for Oral Mucositis

Award Number: R44DE019740
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2009
PERIOD OF PERFORMANCE END DATE: 03/30/2013

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Antimicrobial and Regenerative Treatment for Oral Mucositis - DESCRIPTION (provided by applicant): Oral mucositis is a frequent and painful complication of chemotherapy, radiotherapy and immune compromise. Mucositis is associated with significant morbidity including pain, oral lesions, dehydration and nutritional compromise including limiting calorie intake and malnutrition as well as the high risk for systemic infection. In addition, mucositis can lead to systemic toxicities and is associated with symptom complexes that include fatigue, and mood change. The complexity of mucositis pathology is compounded, particularly in the case of myelosuppressed and immunocompromised individuals, by opportunistic pathogens. Current management does not prevent mucosal except in limited indications and do not provide reliable resolution of mucosal lesions. Because of the multi-faceted components contributing to the severity of mucositis, a wide variety of treatment options have been tested including simple oral hygiene, infection prevention, anti- inflammatory agents, reactive oxygen species, salivary function modifiers, coating agents and growth factors. Although these therapies may have efficacy in some cases, a more comprehensive treatment approach is urgently needed. Synedgen is developing an antimicrobial platform based on soluble chitosan derivatives that rapidly clump bacteria, disrupt their biofilms and ultimately kill a wide variety of resistant and non-resistant strains. In addition, the soluble chitosan derivative has demonstrated anti-inflammatory properties and the ability to stimulate wound regeneration. This research aims to provide in vitro data to assess the doses, treatment regimes and formulations that will be effective in prophylaxis and in enhancing resolution of oral mucositis induced by radiation in pre-clinical animal studies. In vitro studies will assess the chitosan derivative's effect on the ability of bacteria to form biofilms and effect on wound healing. Testing in animal models will demonstrate the appropriate dosing and formulation for efficacy in preventing bacterial colonization as well as provide clear evidence of the products ability enhance the natural history of onset to healing in an animal model. Toxicology studies required by the FDA will be contracted to assure compliance with regulatory guidelines. With successful demonstration of efficacy and safety of this oral care product, Phase 2 testing in human trials can be initiated with a goal of rapid commercialization. The successful result of this work will be the optimization of safe and effective formulation, administration protocol and completion of pre-clinical testing required for a highly effective oral therapy that clinical prevents opportunistic infection, and enhances the healing process of oral lesions. PUBLIC HEALTH RELEVANCE: Oral mucositis is a painful, debilitating complication that occurs regularly with chemotherapy, radiation treatment or immuno-suppressants. While many treatments exist to manage the pain and begin to control the outcomes of the lesion development, few treatments are effective. This funding supports an effort to develop an FDA approved daily oral treatment that prevents bacterial infection and complications in mucositis while actively promoting healing and resolution of the oral lesions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2012	SYNEDGEN, INC.	1420 N CLAREMONT BLVD STE 105D	CLAREMONT	CA	91711	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	3	5/11/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $970,980 )
2012	2012	SYNEDGEN, INC	1420 N Claremont Blvd 105d	Claremont	CA	91711	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	3	3/21/2012	NON-COMPETING CONTINUATION	$970,980
														Subtotal = $970,980

Issue Date FY: 2011 ( Subtotal = $992,846 )
2011	2011	SYNEDGEN, INC	1420 N Claremont Blvd 105d	Claremont	CA	91711	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	2	3/4/2011	COMPETING CONTINUATION	$868,268
2011	2011	SYNEDGEN, INC	1420 N Claremont Blvd 105d	Claremont	CA	91711	LOS ANGELES	USA	Oral Diseases and Disorders Research	001	2	3/18/2011	COMPETING CONTINUATION	$124,578
														Subtotal = $992,846

Grand Total All Awards = $1,963,826

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Antimicrobial and Regenerative Treatment for Oral Mucositis

Award Number: R44DE019740

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2009

PERIOD OF PERFORMANCE END DATE: 03/30/2013

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