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PLGA encapsulated polyphenols to ameliorate IBD.

Award Number: R43AT009800
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2020

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PLGA encapsulated polyphenols to ameliorate IBD. - Abstract Green tea has received increased attention recently, due to several epidemiological and clinical studies showing a positive relationship between consumption and disease prevention. Benefits include reduced risk of cardiovascular diseases (e.g. myocardial infarction, hypertension, atherosclerosis), neurodegenerative diseases (e.g. Parkinson’s and Alzheimer’s disease), and certain cancers (e.g. gastric, breast and cervical cancer). Supplements can even help maintain healthy body weight and lipid profiles. Clinical activity has been demonstrated in leukemia and by our group in inflammatory bowel disease (IBD). These effects are attributed to the polyphenolic flavonoid compounds known as catechins (i.e., polyphenols) present in high amounts. Yet, poor stability, low oral bioavailability and inconsistent intestinal absorption remain problematic. If these shortcomings were overcome, the impact of green tea supplementation could be dramatically improved and novel, efficacious pharmaceutical products aimed at maintaining health developed. The hypothesis behind this application is that encapsulation into poly D,L-lactide-co-glycolide (PLGA) microspheres will improve the delivery and thus efficacy of green tea’s polyphenols via the oral route. Importantly, PLGA is already approved by the FDA and EMA for human use. Thus, PLGA-based micro-particles are in a good position for use in products intended for human consumption. Considering these observations, the proposed studies will test an oral PLGA encapsulated polyphenol formulation for prophylactic use. In Aim 1, we will determine whether oral administration of polyphenol loaded microspheres is superior to parenteral soluble material in limiting murine IBD using a prophylactic iteration of the acute DSS-induced colitis model. We will then optimize the prophylactic protocol and examine the effects of treatment on the phenotypic and functional properties of colonic LP and MLN mononuclear cells. In Aim 2, we will determine whether oral administration of polyphenol microspheres is similarly effective in the CD4+CD25- T-cell reconstituted SCID mouse model of colitis This model is also in routine operation in our laboratory. We will elucidate immunological mechanisms, as well as monitor long-term efficacy and systemic side effects. Future work will include pharmacokinetic, dose-ranging toxicology studies, as well as product development (drug product and drug substance) efforts aimed at novel pharmaceutical products. If the proposed studies are successful the hope is that the benefits of green tea, long recognized by the ancients, may at last be translated and optimized into prophylactic benefit for IBD patients.


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: 2021 ( Subtotal = $0 )
2021	2018	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	000	1	10/19/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $320,159 )
2018	2018	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Research and Training in Complementary and Integrative Health	000	1	6/8/2018	NEW	$320,159
														Subtotal = $320,159

Grand Total All Awards = $320,159

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PLGA encapsulated polyphenols to ameliorate IBD.

Award Number: R43AT009800

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2020

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