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Sustained release gel enabling one-stage treatment of prosthetic joint infection

Award Number: R44AR070685
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: 08/01/2016
PERIOD OF PERFORMANCE END DATE: 07/31/2019

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Sustained release gel enabling one-stage treatment of prosthetic joint infection - Principal Investigator: Overstreet, Derek J. Abstract Sonoran Biosciences, Inc. SBIR PAR-14-088: Direct Phase II Prosthetic joint infections (PJIs) are especially costly, requiring two surgeries at a cost of approximately $100,000 per case to treat more than 40,000 hip and knee replacement infections each year. The near-term outlook in this area is bleak with the number of infections growing over 9% per year and few promising technologies on the horizon. At the same time, healthcare reforms are putting increasing economic pressure on hospitals tasked with managing PJIs. PJIs are caused by bacteria in biofilms which require extreme, sustained concentrations of antimicrobials to eradicate. PJIs are treated with a combination of thorough surgical removal of the infected implant and tissues (debridement) followed by local delivery of high concentrations of antimicrobials to eradicate any residual biofilm contamination. Currently, local delivery is achieved using bone cement "spacers" which require removal. A degradable local delivery formulation compatible with insertion of a permanent implant would enable effective PJI treatment in a single surgery, improving patient outcomes and reducing costs by about half. We have developed a new viscous controlled-release carrier, SB Gel, which is capable of providing high and sustained antimicrobial concentrations over the entire surface of a joint prosthesis and throughout a surgical site. SB Gel is the only material to combine sustained multi- day antibiotic release to eliminate contamination in the surgical site (including biofilm), compatibility on implant surfaces, and safe degradation to allow for normal healing. Preliminary studies demonstrate that SB Gel provides appropriate release rates to kill biofilm, does not hinder normal bone healing onto gel-coated implants, is safe at multiples of the human equivalent dose, and is reliably effective (20/20) in a model of one-stage treatment of deep implant infection. We now propose continuing development in a Phase II project to develop a formulation of SB Gel loaded with the antimicrobials tobramycin and vancomycin for treatment of PJI in a single surgery. Tobramycin and vancomycin have collective activity against bacteria responsible for over 95% of orthopaedic infections including PJIs. Aim 1 studies will ascertain the advantage of using two antimicrobials rather than one, evaluate bone-implant healing in a load-bearing hip replacement model, measure clearance of the SB Gel polymer after degradation, and measure in vivo delivery rates. Aim 2 will focus on optimizing the gel formulation, including evaluation of shelf life and development of a predictive model for critical quality attributes of the gel. In Aim 3, a selected formulation will be evaluated in GLP toxicity and pharmacokinetics studies in rats, a key component of the definitive testing required to proceed to clinical trials.


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: 2019 ( Subtotal = $0 )
2019	2017	SONORAN BIOSCIENCES, INC.	1048 E KNIGHT LN	TEMPE	AZ	85284	MARICOPA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	8/6/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $919,432 )
2017	2017	SONORAN BIOSCIENCES, INC.	3931 W BUTLER ST	CHANDLER	AZ	85226	MARICOPA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	7/28/2017	NON-COMPETING CONTINUATION	$919,432
														Subtotal = $919,432

Issue Date FY: 2016 ( Subtotal = $564,985 )
2016	2016	SONORAN BIOSCIENCES INC	3931 WEST BUTLER STREET	CHANDLER	AZ	85226	MARICOPA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	7/11/2016	NEW	$564,985
														Subtotal = $564,985

Grand Total All Awards = $1,484,417

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Sustained release gel enabling one-stage treatment of prosthetic joint infection

Award Number: R44AR070685

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: 08/01/2016

PERIOD OF PERFORMANCE END DATE: 07/31/2019

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