# Oleocanthal functional food products for breast cancer recurrence control

> **NIH NIH R41** · OLEOLIVE, INC. · 2020 · $399,999

## Abstract

SUMMARY
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 treatment options. The Mediterranean olive oil-rich
diet is documented to reduce BC incidence. (-)-Oleocanthal (OC) is a natural phenolic exclusively occurring in
extra-virgin olive oil (EVOO). It showed selective anti-BC activities. Dysregulated HGF/MET pathway, the
validated major OC molecular target, correlates with initiating aggressive and recurrent TNBC profile. A unique
OC taste-masked, dissolution enhancing and chemical integrity maintaining solid dispersion formulation (OC-X)
was developed and characterized.
 The central hypothesis is that oral OC-X will be effective as a preventive and therapeutic to control
locoregional TNBC recurrence. The following aims will test this hypothesis. Aim 1: Perform dose dependent
studies to determine the optimal effective dose of orally administered OC-X on tumor recurrence in nude mice
and pharmacokinetics in Swiss albino mice. This Aim will assess efficacy of OC-X in preventive, treatment, after
completion of paclitaxel neoadjuvant regimen and bioavailability. Aim 2: Perform dose dependent studies to
determine the optimal effective dose of orally administered OC-X on tumor recurrence in MMTV-PyMT transgenic
mouse model. This human-mimicking heterogenic model will be used to assess recurrence (after surgical
excision of early mammary gland tumors) and metastasis inhibitory effects of OC-X. Expected outcomes: The
intake of OC in EVOO over human history and the lack of other safe therapeutic alternatives qualify this important
bioactive natural product for long-term use to prevent breast and MET-dependent cancers recurrence. Validation
of an OC nutraceutical product will facilitate its commercialization for long-term use to prevent recurrence in BC
patients and survivors.

## Key facts

- **NIH application ID:** 10008278
- **Project number:** 1R41CA247025-01A1
- **Recipient organization:** OLEOLIVE, INC.
- **Principal Investigator:** KHALID A EL SAYED
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $399,999
- **Award type:** 1
- **Project period:** 2020-06-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10008278

## Citation

> US National Institutes of Health, RePORTER application 10008278, Oleocanthal functional food products for breast cancer recurrence control (1R41CA247025-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10008278. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*