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BMX-001 as a Therapeutic Agent for Treatment of High-Grade Gliomas

Award Number: R44CA195749
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/18/2015
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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BMX-001 as a Therapeutic Agent for Treatment of High-Grade Gliomas - PROJECT SUMMARY/ABSTRACT A randomized, proof-of-concept, Phase 2 clinical trial of a new class of redox-active pharmaceutical is proposed in 160 subjects undergoing primary treatment for high-grade glioma (WHO grade III and IV). Under a prior Phase II SBIR, a Phase 1 clinical trial has been completed with establishment of the recommended dose being used for this Phase 2 clinical trial. This project will test a compound that, in animals, has been demonstrated to cross the blood-brain barrier and prevent hippocampal stem cell loss and white matter degradation following radiation therapy (RT). The compound also enhances tumor killing in combination with radiation therapy and thus has the dual impact of protecting normal tissues while improving tumor treatment responses. This drug is both neuroprotective against RT and is expected to enhance inhibition of glioblastoma by RT. Primary brain tumors represent 1% of all diagnosed cancers. Even though these tumors represent a rare malignancy, high-grade gliomas are aggressive and lethal and are associated with severe disabling central nervous system involvement. Cognition and neurological function are compromised at diagnosis and during treatment. The standard of care for newly diagnosed high-grade gliomas involves surgical resection, followed by RT with concurrent temozolomide (TMZ). Despite aggressive treatment, nearly all patients with the most common form of adult primary brain tumor, glioblastoma (WHO grade IV), die of disease progression; median survival is 12-16 months after diagnosis. Most high-grade gliomas are resistant to current available therapies. Thus, a major require- ment for the next generation therapy of primary brain tumors is more effective tumor control, protection against neurotoxicity, and reduction in the incidence of bone marrow suppression (i.e., thrombo- cytopenia). The Phase 2 clinical trial proposed in this SBIR Phase IIB Bridge Award is to test the hypothesis that BMX-001, the lead compound in a new class of redox-active metalloporphyrins, will extend patient survival and at the same time protect normal tissues and enhance quality of life. The specific aims are to: 1) confirm enhanced survival (tumor control) by completing a randomized, open- label Phase 2 clinical trial of BMX-001 in combination with standard RT and TMZ in newly diagnosed high-grade glioma patients (160 subjects, 1:1 randomization), and 2) confirm protection from side effects of radiochemotherapy by assessing cognition, white matter integrity, quality of life (HRQoL) and bone marrow protection. The primary outcomes are 1) Efficacy based on overall and progression-free survival; 2) Protection/improvement of cognition; 3) Radiographic response of tumor; and 4) Protection of bone marrow against chemotherapy-induced thrombocytopenia. Exploratory outcomes are 1) HRQoL and 2) White matter integrity (MRI brain diffusion tensor imaging).


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: 2024 ( Subtotal = $0 )
2024	2021	BIOMIMETIX JV, LLC	5340 S QUEBEC ST STE 345N	GREENWOOD VILLAGE	CO	80111	ARAPAHOE	USA	Cancer Treatment Research	000	4	1/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,625 )
2022	2022	BIOMIMETIX JV LLC	5340 S QUEBEC ST	GREENWOOD VILLAGE	CO	80111	ARAPAHOE	USA	Cancer Treatment Research	000	4	5/17/2022	SUPPLEMENT FOR EXPANSION	$1,625
														Subtotal = $1,625

Issue Date FY: 2021 ( Subtotal = $2,000,000 )
2021	2021	BIOMIMETIX JV, LLC	5340 S QUEBEC ST STE 345 N	GREENWOOD VILLAGE	CO	80111	ARAPAHOE	USA	Cancer Treatment Research	000	4	8/9/2021	NON-COMPETING CONTINUATION	$2,000,000
														Subtotal = $2,000,000

Issue Date FY: 2020 ( Subtotal = $2,000,000 )
2020	2020	BIOMIMETIX JV, LLC	4650 S FOREST ST	ENGLEWOOD	CO	80113	ARAPAHOE	USA	Cancer Treatment Research	000	3	5/22/2020	COMPETING CONTINUATION	$2,000,000
2020	2016	BIOMIMETIX JV, LLC	5340 S QUEBEC ST STE 345 N	GREENWOOD VILLAGE	CO	80111	ARAPAHOE	USA	Cancer Treatment Research	001	2	9/28/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,000,000

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2016	BIOMIMETIX JV, LLC	4650 S FOREST ST	ENGLEWOOD	CO	80113	ARAPAHOE	USA	Cancer Treatment Research	000	2	6/17/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	BIOMIMETIX JV, LLC	4650 S FOREST ST	ENGLEWOOD	CO	80113	ARAPAHOE	USA	Cancer Treatment Research	000	2	8/17/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $1,023,555 )
2016	2016	BIOMIMETIX JV, LLC	4650 S FOREST ST	ENGLEWOOD	CO	80113	ARAPAHOE	USA	Cancer Treatment Research	000	2	7/28/2016	NON-COMPETING CONTINUATION	$1,023,555
														Subtotal = $1,023,555

Issue Date FY: 2015 ( Subtotal = $976,447 )
2015	2015	BIOMIMETIX JV, LLC	4650 S FOREST ST	ENGLEWOOD	CO	80113	ARAPAHOE	USA	Cancer Treatment Research	000	1	9/16/2015	NEW	$976,447
														Subtotal = $976,447

Grand Total All Awards = $6,001,627

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BMX-001 as a Therapeutic Agent for Treatment of High-Grade Gliomas

Award Number: R44CA195749

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/18/2015

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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