# Development of Novel Herbal Therapy for Prevention of Irinotecan-induced Severe Delayed Onset Diarrhea

> **NIH NIH R43** · SANARENTERO LLC · 2020 · $325,000

## Abstract

PROJECT SUMMARY / ABSTRACT
Cancer is the second leading cause of death in the United States. According to American Cancer Society
statistics, about 1.76 million new patients are expected to be diagnosed with cancer and about 600,000
people are expected to die due to cancer in the United States in 2019. Approximately 6-10% of the total
cancer patients are diagnosed with stage IV/metastatic cancer, while 30-50% develop metastasis during
disease progression. Through the advent of new and effective drugs for cancer treatment, 5-year survival
rate for cancer has improved to about 67%, however treatment of refractory/recurrent disease in
metastatic cancer patients remains a critical challenge. Among the various cancer drugs available for
metastatic cancer treatment, irinotecan is often the drug of last resort for the refractory diseases.
Recent clinical studies have indicated that high-dose irinotecan therapy can be successfully used in
patients with refractory diseases, even in irinotecan-refractory patients, improving life expectancy
of cancer patients. However, irinotecan treatment is currently limiting due to severe and sometimes
life-threatening dose-limiting site effects (i.e. neutropenia and severe delayed onset diarrhea).
Chemotherapy-induced neutropenia (low white blood cells) is effectively managed with prophylactic
antibiotics and human G-CSF (granulocyte colony stimulating factor) agents in clinics. However, in
about 15% of patients on standard of care irinotecan therapy, diarrhea is unmanageable with current
drugs such as loperamide, requiring hospitalization and even cessation of therapy. Moreover, most
current treatments only provide symptomatic relief but do not prevent the increasing damage to gut
function and integrity, resulting with consecutive cycles of irinotecan therapy. Based on recent
preliminary data from our collaborator’s lab, Sanarentero is proposing to develop a new herbal
product (SE_H1) which can prevent the irinotecan-induced diarrheal toxicity and gut damage. This
will help improve the quality of life, reduce the cost of treatment by reducing incidences of
hospitalization, and increase the life expectancy of metastatic cancer patients with refractory/recurrent
diseases, by allowing continuation of treatment and high-dose irinotecan therapy. The specific
aims of this Phase I SBIR proposal are to 1) develop a standardized novel proprietary herbal formula
using Caco-2 cells; 2) establish the in vivo efficacy of the proprietary herbal formula for SDOD
prevention; and 3) standardize CMC (Chemistry, Manufacturing, and Controls) of SE_H1 for
Phase II studies. Success of this project will generate a well-characterized, standardized,
safe and efficacious proprietary herbal product for prevention of irinotecan-induced severe
delayed onset diarrhea. It will also provide us with proof-of concept evidence of efficacy and
safety in a preclinical model, therefore derisking the product for further development in phase II
SBIR proposal...

## Key facts

- **NIH application ID:** 10153249
- **Project number:** 1R43AT011165-01A1
- **Recipient organization:** SANARENTERO LLC
- **Principal Investigator:** Rashim Singh
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $325,000
- **Award type:** 1
- **Project period:** 2020-09-21 → 2022-09-20

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10153249

## Citation

> US National Institutes of Health, RePORTER application 10153249, Development of Novel Herbal Therapy for Prevention of Irinotecan-induced Severe Delayed Onset Diarrhea (1R43AT011165-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10153249. Licensed CC0.

---

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