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Oleocanthal functional food products for breast cancer recurrence control

Award Number: R41CA247025
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2022

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Oleocanthal functional food products for breast cancer recurrence control - SUMMARY From Parent Grant (R41CA247025) Triple negative breast cancer (TNBC) represents 20% of the breast cancer (BC) cases in the US. TNBC patients have a poor recurrence-free, overall survival rate, and limited available treatment options. The Mediterranean olive oil-rich diet is documented to reduce BC incidence. (-)-Oleocanthal (OC) is a natural phenolic secoiridoid exclusively occurring in extra-virgin olive oil (EVOO) and it has shown selective anti-BC activities, including preliminary results showing prevention of recurrence of TNBC in animal models. The HGF/Met signaling pathway, a validated major OC molecular target, is likely involved in initiating aggressive and recurrent TNBC in a subset of patients. To improve taste, dissolution and stability, a solid dispersion formulation of OC (OC-X) was recently developed and characterized. We hypothesize that the EVOO powdered formulation of OC, OC-X, could be developed as a nutraceutical product to help control locoregional TNBC recurrence. This will be tested in the following Specific Aims. In the first aim, we will perform dose dependent studies to determine the optimal effective dose of orally administered OC-X on tumor recurrence in a nude mouse model after primary tumor surgical resection. This aim will assess the efficacy of formulations in preventive, treatment, and after completion of paclitaxel neoadjuvant regimen modes. In the second aim, we will perform dose dependent studies to determine the optimal effective dose of orally administered OC-X on tumor recurrence in the MMTV-PyMT transgenic mouse model. This immune competent mouse model develops BC mimicking progression seen in human patients and will be used to assess BC recurrence (after surgical excision of early mammary gland tumors) and metastasis following treatment with OC-X. Expected outcomes: EVOO enriched in OC has been safely consumed throughout human history with increasing evidence of effectiveness against many human pathologies, including BC. Given the lack of other safe therapeutic alternatives, OC is a candidate bioactive natural product that could be safe for long-term use to prevent BC recurrence. The data generated by this project will be combined with future studies of OC-X to facilitate commercialization of OC-X as a nutraceutical product to prevent BC recurrence.


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: 2023 ( Subtotal = -$15,233 )
2023	2021	OLEOLIVE, INC.	2031 KINGS HWY	SHREVEPORT	LA	71103	CADDO	USA	Cancer Treatment Research	000	1	5/9/2023	SUPPLEMENT FOR EXPANSION	-$15,233
														Subtotal = -$15,233

Issue Date FY: 2021 ( Subtotal = $54,756 )
2021	2021	OLEOLIVE, LLC	2031 KINGS HWY # 204	SHREVEPORT	LA	71103	CADDO	USA	Cancer Treatment Research	000	1	5/14/2021	SUPPLEMENT FOR EXPANSION	$54,756
														Subtotal = $54,756

Issue Date FY: 2020 ( Subtotal = $399,999 )
2020	2020	OLEOLIVE, LLC	2031 KINGS HWY # 204	SHREVEPORT	LA	71103	CADDO	USA	Cancer Treatment Research	000	1	6/1/2020	NEW	$399,999
														Subtotal = $399,999

Grand Total All Awards = $439,522

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Oleocanthal functional food products for breast cancer recurrence control

Award Number: R41CA247025

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2022

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