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Emodin as a complementary dietary therapy to reduce toxicity of 5 fluorouracil

Award Number: R41AT009964
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: 09/30/2018
PERIOD OF PERFORMANCE END DATE: 09/29/2020

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Emodin as a complementary dietary therapy to reduce toxicity of 5 fluorouracil - PROJECT SUMMARY 5 fluorouracil (5FU) has been the first choice chemotherapy drug for colorectal cancer (CRC) for many years; however, its clinical utility remains hindered by hematopoietic and gastrointestinal toxicities resulting from its non-selectivity. Side effects include fatigue, loss of appetite, and diarrhea among others, all of which can lead to reduced quality of life. The economic burden associated with chemotherapy toxicity is substantial; a single hospitalization for prevention of neutropenia, a common side effect of chemotherapy, can cost $47,000. Given that inflammation has been linked to 5FU associated toxicities, targeting inflammation may minimize anticancer agent-associated toxicity, optimize cancer treatment dosing, and improve clinical outcomes. Thus, identifying strategies to reduce toxicity of 5FU is critical to prevent discontinued or de-escalated treatment. Emodin, a natural anthraquinone derivative found in various Chinese medicinal herbs has been recognized for its ability to target NF-¿B and subsequently reduce inflammation. However, its effects on 5FU associated toxicity and adverse physiological effects (i.e. reduced body weight, physical inactivity, fatigability, pain, and muscle weakness) have not yet been studied. We have collected convincing preliminary data that supports further investigation of emodin as a complementary agent to use with 5FU chemotherapy in CRC: 1) we have reported that emodin is an effective anti-inflammatory agent that acts directly on NF-¿B; 2) we show that emodin is effective at reducing tumorigenesis including CRC; 3) we show that emodin can abolish 5FU chemotherapy induced intestinal inflammation and mucositis; 4) we indicate that emodin can offset the aforementioned adverse physiological outcomes that are associated with 5FU administration; and 5) we show that the doses of emodin that promotes these beneficial effects do not exhibit any side effects. The long-term goal is to move this fundamentally novel complementary dietary compound towards human clinical trials as an innovative agent for use with chemotherapy. In this Phase I STTR project we will rigorously test the hypothesis that dietary emodin will reduce the toxicity associated with 5FU chemotherapy and this will result in improved therapeutic outcome. Three specific aims are proposed: 1) evaluate the effect of emodin on toxicity and adverse effects associated with 5FU chemotherapy, 2) establish the effective plasma and colon tissue levels and dosing interval for emodin, and 3) perform a subchronic oral toxicity screening of emodin in mice. The success of our proposed phase I STTR study will further the development of emodin as a new complementary strategy for use with chemotherapy in CRC. This safe, effective, and low-cost agent has the potential to reduce the toxicity and increase the efficacy of chemotherapy agents. A follow-up Phase II STTR program will expand on these initial studies to: 1) complete efficacy studies of emodin and 5FU combination in mouse models of CRC and 2) complete advanced pharmaceutical toxicology studies in mice. The overall goal of Phase II will be to position AcePre LLC for an FDA Pre-Investigational New Drug package.


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	ACEPRE, LLC	6439 GARNERS FERRY RD BLDG 1 C53	COLUMBIA	SC	29209	RICHLAND	USA	Research and Training in Complementary and Integrative Health	000	1	12/15/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $38,933 )
2019	2019	ACEPRE, LLC	6439 GARNERS FERRY RD BLDG 1 C53	COLUMBIA	SC	29209	RICHLAND	USA	Research and Training in Complementary and Integrative Health	001	1	1/31/2019	SUPPLEMENT FOR EXPANSION	$38,933
2019	2018	ACEPRE, LLC	6439 GARNERS FERRY RD BLDG 1 C53	COLUMBIA	SC	29209	RICHLAND	USA	Research and Training in Complementary and Integrative Health	000	1	10/23/2018	NEW	$0
														Subtotal = $38,933

Issue Date FY: 2018 ( Subtotal = $261,212 )
2018	2018	ACEPRE, LLC	6439 GARNERS FERRY RD BLDG 1 C53	COLUMBIA	SC	29209	RICHLAND	USA	Research and Training in Complementary and Integrative Health	000	1	9/20/2018	NEW	$261,212
														Subtotal = $261,212

Grand Total All Awards = $300,145

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Emodin as a complementary dietary therapy to reduce toxicity of 5 fluorouracil

Award Number: R41AT009964

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: 09/30/2018

PERIOD OF PERFORMANCE END DATE: 09/29/2020

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