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Clinical Safety and Pharmacokinetics of Sustained Release Depot Tacrolimus

Award Number: U44AI069674
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2007
PERIOD OF PERFORMANCE END DATE: 07/31/2019

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Clinical Safety and Pharmacokinetics of Sustained Release Depot Tacrolimus - PROJECT SUMMARY: The long term goal of this research is to reduce toxicity and graft rejection due to dosing problems with the calcineurin inhibitors by developing a sustained release subcutaneous injectable formulation of the calcineurin inhibitor tacrolimus. Substantial inter-and intra-patient variability of tacrolimus due to genomic heterogeneity means that even frequent drug monitoring cannot eradicate rejection due to sub-therapeutic troughs, or toxicity due to unavoidable peak levels. In addition, non-adherence with the daily oral dosing regimen is a major cause of graft failure especially in adolescent patients. The potency and the long elimination half-life of tacrolimus makes it suitable for depot formulation, and pharmacokinetic modeling suggests that a formulation that could allow periodic subcutaneous dosing is feasible. We hypothesize that use of such a formulation could reduce or eliminate many of the problem of bioavailability, toxicity, and adherence. Funded by SBIR Phase I and II grants, we developed sustained release (SR) formulations for tacrolimus, measured its in vitro dissolution and demonstrated tolerability and sustained release in an in vivo model. Based on this work, we were granted an IND (No. 124601) to perform a 28-day study in six normal, healthy volunteers to assess the safety and preliminary pharmacokinetics (PK) of our proposed formulation. The specific aims of this proposal are to manufacture clinical trial lots of SR injectable tacrolimus as described in IND 124601; to perform a clinical, first -in-human 28 day safety and PK study; to submit the safety and PK data from the 28 day trial to the FDA; and to analyze the data and plan further studies. The milestone for successful completion of this two-year Phase II work is the successful completion of a clinical trial demonstrating safety and sufficient drug release to merit proceeding to further development in pursuit of a New Drug Approval.


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: 2020 ( Subtotal = $0 )
2020	2017	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Allergy and Infectious Diseases Research	000	5	3/18/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $711,144 )
2017	2017	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Allergy and Infectious Diseases Research	001	5	7/25/2017	NON-COMPETING CONTINUATION	$766,264
2017	2016	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Allergy and Infectious Diseases Research	000	4	7/24/2017	COMPETING CONTINUATION	-$55,120
														Subtotal = $711,144

Issue Date FY: 2016 ( Subtotal = $587,940 )
2016	2016	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	8/12/2016	COMPETING CONTINUATION	$587,940
														Subtotal = $587,940

Grand Total All Awards = $1,299,084

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Clinical Safety and Pharmacokinetics of Sustained Release Depot Tacrolimus

Award Number: U44AI069674

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/15/2007

PERIOD OF PERFORMANCE END DATE: 07/31/2019

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