# Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer

> **NIH VA I01** · ALBUQUERQUE VA MEDICAL CENTER · 2022 · —

## Abstract

Ample preclinical data suggests that grape seed procyanidin extract (GSE) possesses multi-faceted anticancer
properties. GSE has been shown to favorably modulate carcinogenic mechanisms, including 1) major
eicosanoids pathways, such as inhibitions of cyclocoxygenase (COX)-2/prostaglandin (PG)E2, induction of
prostacyclin synthase (PTGIS)/PGI2 and increase production of 15(S)-hydroxy-eicosatetraenoic acid (15-HETE);
2) downregulation of oncomirs microRNA (miR)-19a, -19b and up-regulations of their downstream targets - tumor
suppressors insulin-like growth factor II receptor (IGF-2R) and phosphatase and tensin homolog (PTEN),
resulting in reduction of phosphorylated (P)-AKT, as well as downregulation of oncomir miR-106b and
upregulation of its target – the tumor suppressor P21. Recently, we have found that oral leucoselect phytosome
(LP), a standardized GSE complexed with soy phospholipid to enhance bioavailability, significantly inhibited
human lung cancer xenograft growth, reduced bronchial Ki-67 labeling index (a marker of proliferation), favorably
modulated major eicosanoids pathways, and downregulated serum miR-19a, -19b, and -106b in heavy
current/former smokers. We therefore hypothesize that oral administration of LP is safe, can favorably modulate
mechanisms associated with lung cancerization, and be useful for lung cancer treatment. To test these
hypotheses, a single arm, phase IIa neoadjuvant lung cancer treatment study using LP, will be conducted in 30
patients with newly diagnosed, stage I and II resectable lung cancer.
Aim #1: will determine the safety, feasibility and pharmacokinetics (PK)/pharmacodynamics (PD) of 2-3 weeks
of oral LP in stage I or II nonsmall cell lung cancer (NSCLC) patients prior to resection. Subjects will consent to
study participation and archive of specimens for research, including blood, urine, and from diagnostic
procedures, such as bronchoscopy [bronchoalveolar lavage (BAL) fluid and cells, lesion biopsies and lymph
node (LN) sampling] and/or transthoracic needle aspiration (TTNA) as clinically indicated, to be used as pre-
treatment samples. Qualified subjects who are diagnosed with resectable lung cancer will be enrolled and treated
for ~2-3 weeks until surgical resection. At the time of surgery, serial clinical specimens, including BAL, LN, lung
tumor/adjacent tissue, blood and urine will be collected as post-treatment samples for assessing
PK/bioavailability, PD and mechanism of actions when applicable. The safety of oral LP will be monitored weekly
with the NCI common terminology criteria for adverse events Version 5.0 and adverse reaction questionnaires.
Aim #2: To determine the antineoplastic and mechanistic effects of oral LP in stage I/ II lung cancer patients.
The anticancer effects of LP will be assessed by comparing its bioactivity pre- vs. post-treatment, as measured
by modulations of tumor pathological response, downstaging, Ki-67 labeling index, activated caspase 3
(apoptosis marker), COX-2, P...

## Key facts

- **NIH application ID:** 10316152
- **Project number:** 5I01CX002028-02
- **Recipient organization:** ALBUQUERQUE VA MEDICAL CENTER
- **Principal Investigator:** JENNY T MAO
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2020-10-01 → 2025-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10316152

## Citation

> US National Institutes of Health, RePORTER application 10316152, Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer (5I01CX002028-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10316152. Licensed CC0.

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