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Mitigation of Radiation Therapy Induced Neuroinflammation and Cognitive Dysfunction

Award Number: R42CA236382
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2021

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Mitigation of Radiation Therapy Induced Neuroinflammation and Cognitive Dysfunction - PROJECT SUMMARY Cognitive decline and deterioration of long-term cognitive performance are major side effects of CNS cancer treatment. Brain metastases are the most common CNS malignancies and a common cause of morbidity and mortality in about 40% of all cancer patients with systemic disease, affecting over 170,000 patients in the US annually. As most systemic chemotherapy agents do not cross the blood brain barrier, the main treatment modalities for brain metastases include surgery, whole brain radiation therapy (WBRT)) and/or stereotactic radiosurgery. The multidisciplinary management of brain metastases aims to achieve durable tumor control within the brain without compromising neurocognitive functioning. However, current results are disappointing. Despite the advantages of WBRT for disease control, cognitive impairment can be seen as early as 3 to 4 months after WBRT, and affects approximately 80-90% of patients, with memory and executive function being the major cognitive domains affected. Abnormal levels of proinflammatory cytokines (PIC) induced in response to ionizing radiation have been proposed as a potential mechanism underlying WBRT-induced cognitive impairment. Shortly after radiation treatment of a tissue, a cascade of cytokines and chemokines is initiated and these mediators perpetuate and augment the inflammatory response for long periods of time, leading to chronic inflammation and tissue injury. MW151 is an orally active, small molecule drug candidate that restores injury- or disease-induced dysregulation of PIC production towards homeostasis without immunosuppression. MW151 selectively attenuates the PIC cascade that occurs in a diverse array of animal models, including mitigation of CNS and skin radiation injury even when given days after radiation exposure. Our goal in the proposed clinical feasibility study is to test the hypothesis that plasma PIC levels are stabilized in patients receiving MW151 in the course of WBRT for the treatment of brain metastases and that MW151 treatment can attenuate therapy-induced cognitive dysfunction in these patients. Our specific aims are: Aim 1 – Preparation for clinical study. Aim 2 – Recruitment and conduct of the clinical study. Aim 3: Evaluation of clinical study outcomes. This pilot study will provide data regarding the feasibility of the clinical use of MW151 as an adjunct to WBRT, the current standard of care, to reduce the cognitive decline after radiation therapy for patients with brain metastases.


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: 2021 ( Subtotal = $0 )
2021	2019	IMMUNOCHEM THERAPEUTICS, LLC	105 AUBURN ST	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Treatment Research	000	1	7/29/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	IMMUNOCHEM THERAPEUTICS, LLC	105 AUBURN ST	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Treatment Research	000	1	3/2/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $224,888 )
2019	2019	IMMUNOCHEM THERAPEUTICS, LLC	105 AUBURN ST	NEWTON	MA	02466	MIDDLESEX	USA	Cancer Treatment Research	000	1	4/30/2019	NEW	$224,888
														Subtotal = $224,888

Grand Total All Awards = $224,888

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Mitigation of Radiation Therapy Induced Neuroinflammation and Cognitive Dysfunction

Award Number: R42CA236382

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2021

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