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Development of magnetic hyperthermia for the systemic treatment of endometriosis

Award Number: R01HD101450
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Development of magnetic hyperthermia for the systemic treatment of endometriosis - Summary/Abstract (30 lines) Thermal therapy is a clinical intervention to eradicate cancerous tissue by increasing the temperature of the tumors. Nanoparticle-mediated magnetic hyperthermia is a form of thermal therapy where magnetic nanoparticles delivered to cancer sites generate heat after exposure to an external alternating magnetic field (AMF). The goal of this project is to advance nanoparticle-mediated magnetic hyperthermia as a non-invasive treatment for endometriosis. Endometriosis is a disorder where endometrium-like tissue is present at “ectopic” sites outside of the uterus. The ectopic endometrium forms lesions that cause pelvic pain and infertility. Despite advances in therapies for endometriosis-related pelvic pain, there remains no medical cure for the disorder, and surgical removal of the lesions remains a treatment for many women. Unfortunately, the rate of disease recurrence exceeds 50% with many patients requiring three or more surgeries. The premise of this proposal is that magnetic hyperthermia can provide a non-surgical option to remove endometriotic lesions. Magnetic hyperthermia for cancer is currently restricted to the treatment of localized and accessible tumors because the required therapeutic temperatures (≥42 0C) can only be achieved by direct intratumoral injection of conventional magnetic nanoparticles. To address this limitation, this research team invented novel magnetic nanoclusters with high heating capacity. The nanoclusters consist of hexagonal-shaped magnetic nanoparticles encapsulated in polymeric vehicles. Animal studies validated that these nanoclusters are safe, efficiently accumulate in cancer tumors after intravenous (IV) injection, and elevate the intratumoral temperature to 44 0C in the presence of AMF. Preliminary studies revealed that following IV injection these nanoclusters also efficiently accumulated in the macaque endometriotic lesions grafted into severe combined immunodeficient (SCID) mice and exposure of these mice to external AMF after nanoclusters delivery increased the temperature inside of the grafts up to 43 0C. To advance this new therapy this multidisciplinary team of investigators with complementary expertise in nanomedicine, magnetic hyperthermia, and clinical endometriosis research proposes in Specific Aim 1, to optimize targeting efficiency of these nanoclusters to human and macaque endometriosis. Targeting will be optimized by modifying the surface of the nanoclusters with peptides that specifically bind to receptors (e.g., vascular endothelial growth factor (VEGF) receptor 2 (KDR)) overexpressed in primate endometriotic stromal cells. Binding specificity and therapeutic efficacy of these new nanoclusters will be assessed in primary endometrial and endometriosis (human and macaque) stromal cells in vitro. In Specific Aim 2, the effect of targeted versus non-targeted nanoclusters on the eradication of endometriosis lesions will be evaluated in SCID mice engrafted with human and macaque endometriotic grafts. In Specific Aim 3, safety and therapeutic efficacy of magnetic hyperthermia mediated by the optimized nanoclusters will be evaluated in macaques with induced endometriotic lesions.


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: 2025 ( Subtotal = $0 )
2025	2024	OREGON STATE UNIVERSITY	1500 SW JEFFERSON AVE	CORVALLIS	OR	97331	BENTON	USA	Child Health and Human Development Extramural Research	000	4	8/11/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $658,148 )
2024	2024	OREGON STATE UNIVERSITY	1500 SW JEFFERSON AVE	CORVALLIS	OR	97331	BENTON	USA	Child Health and Human Development Extramural Research	000	4	8/27/2024	NON-COMPETING CONTINUATION	$658,148
														Subtotal = $658,148

Issue Date FY: 2023 ( Subtotal = $630,902 )
2023	2023	OREGON STATE UNIVERSITY	1500 SW JEFFERSON ST	CORVALLIS	OR	97331	BENTON	USA	Child Health and Human Development Extramural Research	000	3	8/30/2023	NON-COMPETING CONTINUATION	$630,902
														Subtotal = $630,902

Issue Date FY: 2022 ( Subtotal = $558,519 )
2022	2022	OREGON STATE UNIVERSITY	1500 SW JEFFERSON ST	CORVALLIS	OR	97331	BENTON	USA	Child Health and Human Development Extramural Research	000	2	8/31/2022	NON-COMPETING CONTINUATION	$558,519
														Subtotal = $558,519

Issue Date FY: 2021 ( Subtotal = $568,850 )
2021	2021	OREGON STATE UNIVERSITY	1500 SW JEFFERSON ST	CORVALLIS	OR	97331	BENTON	USA	Child Health and Human Development Extramural Research	000	1	9/17/2021	NEW	$568,850
														Subtotal = $568,850

Grand Total All Awards = $2,416,419

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Development of magnetic hyperthermia for the systemic treatment of endometriosis

Award Number: R01HD101450

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/17/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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