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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA195749-03A1
Agency Tracking Number: R44CA195749
Amount: $4,001,625.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: CA19-047
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-01
Award End Date (Contract End Date): 2023-05-31
Small Business Information
Englewood, CO 80113-6100
United States
DUNS: 079124042
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (303) 398-1657
Business Contact
Phone: (303) 221-3201
Research Institution

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).

* Information listed above is at the time of submission. *

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