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Safety and efficacy testing of novel anti-scar peptide vs corticosteroid for scar

Award Number: R43AR063558
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/18/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2016

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Safety and efficacy testing of novel anti-scar peptide vs corticosteroid for scar - DESCRIPTION (provided by applicant): Cutaneous fibrosis (scarring) affects up to 100 million patients per year in developed countries. Scarring - especially hypertrophic scarring - can have significant morphologic and functional sequelae, requiring multiple revision surgeries to restore function and improve appearance. The incidence of hypertrophic scarring varies 40-70% following surgery, and can be up to 90% following burn injury. Current methods for the treatment of hypertrophic scars are minimally effective or have undesirable side effects. Steroids (e.g. Triamcinolone) are FDA-approved for intralesional injection into hypertrophic scars, but have significant side effects including granulomas and skin atrophy that leads to reduced wound strength. Moreover, many hypertrophic scars are refractory to steroids or other non-surgical therapies and require revision surgery. However, revision surgery for hypertrophic scar also has a high rate of recurrence. Through a sustained, 12 year research effort examining models of fetal wound healing, we have identified fibromodulin (FMOD) as a novel molecule required for fetal scarless skin repair. In a technological innovation, we have identified a 40 amino acid peptide sequence, F06-C40, which has similar anti-fibrotic effects as the 376 amino acid full FMOD protein. Excitingly, we have demonstrated using a pig model of human hypertrophic scarring that both FMOD protein and its peptide derivative F06-C40 can significantly reduce scar formation. In this proposal, we will test the hypothesis that F06-C40 is more efficacious than corticosteroids for reduction of hypertrophic scar formation. AIM 1 (Months 1-12): Optimize F06-C40 for scar prevention in pig hypertrophic scar models and compare it with corticosteroids. AIM 1 will optimize the dose of F06-C40 for hypertrophic scar reduction and compare the optimized formulation with corticosteroid injection. Two wound models in Red Duroc pigs, a porcine breed that most closely simulates human hypertrophic scarring, will be used. Primary outcome measures will include improved gross visual appearance without a reduction in wound tensile strength. AIM 2 (Months 13-24): Accomplish initial safety studies for F06-C40 first-in-man studies. AIM 2 will focus on accomplishing key studies required by the FDA at the pre-IND meeting for F06-C40. Studies will consist of preliminary genotoxicity and intravenous toxicology studies in rats. Hypertrophic scars cause significant functional and cosmetic impairment. This SHIFT SBIR proposal focuses on optimizing the treatment regimen for F06-C40, proving its superior efficacy compared with current strategies for scar reduction, and verifying its initial product safety.


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: 2015 ( Subtotal = $197,827 )
2015	2015	SCARLESS LABORATORIES INC	115 NORTH DOHENY DRIVE	BEVERLY HILLS	CA	90211	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	8/20/2015	NON-COMPETING CONTINUATION	$197,827
														Subtotal = $197,827

Issue Date FY: 2014 ( Subtotal = $198,944 )
2014	2014	SCARLESS LABORATORIES INC	115 NORTH DOHENY DRIVE	BEVERLY HILLS	CA	90211	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/17/2014	NEW	$198,944
														Subtotal = $198,944

Grand Total All Awards = $396,771

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Safety and efficacy testing of novel anti-scar peptide vs corticosteroid for scar

Award Number: R43AR063558

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/18/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2016

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