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Alpha-Particle Emitter Radiopharmaceutical Therapy for Liver Cancer

Award Number: R01CA239041
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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Alpha-Particle Emitter Radiopharmaceutical Therapy for Liver Cancer - Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the fifth most frequently diagnosed cancer worldwide, as well as the second most frequent cause of cancer death. Furthermore, the liver is also the most common site for metastatic cancer. Most patients with advanced disease are offered only non- surgical palliative treatment options. Hepatic tumors derived their blood supply from the hepatic artery whereas normal liver tissue’s blood supply is mainly sourced from the portal vein. Intra-arterial therapies, such as chemoembolization and radioembolization, exploit the hepatic tumors’ blood supply via the hepatic artery to selectively deliver contrast and therapies. Lipiodol is an FDA approved radio-opaque contrast agent used in liver tumor imaging during intra-arterial therapies. Lipiodol accumulates and remains in the tumor while clearing out of normal liver tissue when injected via the hepatic artery, providing a vehicle to deliver therapeutic agents, such as, chemotherapeutics and -emitting radionuclides (188Re and 131I) to liver tumors, but these treatments have limitations, urging the need for development of new therapies. Alpha-emitting radiopharmaceutical therapy (RPT) is highly potent, causing largely irreparable DNA damage to targeted cells. Due to the short range of alpha particles, RPT minimizes damage to nearby healthy cells. The high-energy transfer of alpha particles makes RPT impervious to most resistance mechanisms including pathway redundancy and oxygenation status, a desirable feature for treatment of liver tumors. Lipiodol has detailed information on its pharmacology, formulation and toxicity, due to its FDA-approved status, and its repurposing for RPT can build upon information from previous studies for FDA approval to help rapidly translate a novel RPT agent-Lipiodol emulsion to the clinic. The proposed work is focused on evaluating targeted RPT emulsions for unresectable primary liver cancer as compared to standard of care treatment (Aim 1). A selected RPT emulsion will be tested in a technical rabbit VX2 liver cancer model, allowing us to evaluate these agents’ distribution via the hepatic artery (Aim 2). Finally, the proposed work is focused on the development of a companion imaging agent or the expansion of imaging protocols to allow for a single theranostic agent (Aims 1-3). The successful completion of the proposed research is that an RPT agent-Lipiodol emulsion, based on current FDA approved Lipiodol emulsions, can be repurposed for quick development and evaluation as a therapeutic or theranostic agent for primary and metastatic liver cancer.


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 = -$1,407 )
2025	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	5	4/4/2025	NON-COMPETING CONTINUATION	-$1,407
														Subtotal = -$1,407

Issue Date FY: 2024 ( Subtotal = $574,001 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	5	11/14/2023	NON-COMPETING CONTINUATION	$543,791
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	5	4/16/2024	NON-COMPETING CONTINUATION	$30,210
														Subtotal = $574,001

Issue Date FY: 2023 ( Subtotal = $607,192 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	4	3/14/2023	NON-COMPETING CONTINUATION	$49,566
2023	2023	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	4	11/21/2022	NON-COMPETING CONTINUATION	$557,626
														Subtotal = $607,192

Issue Date FY: 2022 ( Subtotal = $625,918 )
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	3	11/22/2021	NON-COMPETING CONTINUATION	$563,326
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	3	5/10/2022	NON-COMPETING CONTINUATION	$50,075
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	004	3	8/22/2022	NON-COMPETING CONTINUATION	$12,517
2022	2021	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	006	2	9/6/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$55
2022	2021	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	003	2	7/26/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,235
2022	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	005	1	9/6/2022	NEW	-$55
2022	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	002	1	7/26/2022	NEW	-$1,235
														Subtotal = $625,918

Issue Date FY: 2021 ( Subtotal = $639,549 )
2021	2021	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	003	2	5/28/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$289,547
2021	2021	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	2	4/16/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$639,549
2021	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	000	1	4/16/2021	NEW	$0
2021	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	002	1	5/28/2021	NEW	-$289,547
														Subtotal = $639,549

Issue Date FY: 2020 ( Subtotal = $632,025 )
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	000	1	11/20/2019	NEW	$616,795
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	001	1	1/22/2020	NEW	$15,230
														Subtotal = $632,025

Grand Total All Awards = $3,077,278

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Alpha-Particle Emitter Radiopharmaceutical Therapy for Liver Cancer

Award Number: R01CA239041

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/01/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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