# Nanoparticle-based Intraperitoneal Delivery of Combined Chemo-radiotherapy for Treatment of Ovarian Cancer Metastases

> **NIH NIH R44** · NAMI THERAPEUTICS CORP. · 2022 · $1,054,145

## Abstract

PROJECT SUMMARY
Ovarian cancer is the second most common gynecologic cancer in the United States and the most common
cause of death among women with gynecologic malignancies. Despite advances in treatment strategies,
peritoneal metastasis remains the primary cause of morbidity and mortality in ovarian cancer. Recent studies
have suggested that treatment of peritoneal metastasis through intraperitoneal (IP) delivery of therapeutics can
improve patient outcomes; however, there are currently no effective IP-delivered therapies for addressing
peritoneal metastasis, especially for chemoresistant and recurrent patients. Nami Therapeutics (Nami) is
developing an IP-based delivery treatment option for late-stage ovarian cancer. Nami’s approach involves
holmium-166 (166Ho)-containing mesoporous silica nanoparticle (166Ho-MSN)-based radionuclide therapy. 166Ho-
MSNs present a unique approach for treating advanced ovarian cancer in the form of a tumor-specific
radioisotope-containing nanocarrier for internal radiation therapy. Using IP administration, 166Ho-MSNs will be
delivered directly to the peritoneal cavity where they specifically target tumor tissues, limiting radiation exposure
throughout the body via blood circulation, and in turn limiting systemic side effects that are common to other
nanomedicines and chemotherapeutic agents delivered intravenously. Nami successfully completed a Phase I
STTR program that demonstrated (1) enhanced survival in a mouse model of ovarian cancer by treatment with
166Ho-MSNs alone and in combination with chemotherapy; and (2) a favorable safety profile of non-radioactive
165Ho-MSNs in tissues and in systemic toxicity assessments. The Phase I data package supports further
development of the technology through a Phase II program that has a goal of generating a data package to
submit to the FDA to support of clinical development. Specifically, Aim 1 will involve efforts to generate
regulatory-compliant holmium-containing nanoparticles. Aim 2 will focus on generating a target product profile
through the execution of in vivo efficacy studies, and Aim 3 will involve the execution of critical toxicity, biokinetic,
and dosimetry studies. Successful completion of the Phase II program will result in a regulatory submission to
the FDA to allow for the execution of clinical safety and efficacy evaluations of 166Ho-MSNs for treating ovarian
cancer metastases.

## Key facts

- **NIH application ID:** 10479235
- **Project number:** 2R44CA239989-02A1
- **Recipient organization:** NAMI THERAPEUTICS CORP.
- **Principal Investigator:** Michael Jay
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,054,145
- **Award type:** 2
- **Project period:** 2019-09-11 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10479235

## Citation

> US National Institutes of Health, RePORTER application 10479235, Nanoparticle-based Intraperitoneal Delivery of Combined Chemo-radiotherapy for Treatment of Ovarian Cancer Metastases (2R44CA239989-02A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10479235. Licensed CC0.

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