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

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44CA195749-01
Agency Tracking Number: R44CA195749
Amount: $2,000,002.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PAR14-088
Timeline
Solicitation Year: 2014
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-18
Award End Date (Contract End Date): 2019-03-31
Small Business Information
4650 S FOREST ST, Englewood, CO, 80113-6100
DUNS: 079124042
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JAMES CRAPO
 (303) 398-1436
 crapoj@njc.org
Business Contact
 JAMES CRAPO
Phone: (303) 221-3201
Email: jdc@crapodenver.com
Research Institution
N/A
Abstract
DESCRIPTION provided by applicant Phase and Phase clinical trials of a new class of redox active pharmaceutical are proposed in high grade glioma WHO grade III and IV This project will test a compound that crosses the blood brain barrier and which prevents hippocampal stem cell loss and white matter degradation following radiation therapy RT The compound also inhibits tumor regrowth following RT and thus has the dual impact of protecting normal tissues while improving tumor treatment responses This drug is both neuroprotective against RT and a radio sensitizer that is expected to enhance inhibition of glioblastoma by RT Primary brain tumors represent 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 months after diagnosis Most high grade gliomas are resistant to current available therapies Thus a major requirement for the next generation therapy of primary brain tumors requires more effective tumor control and protection against the neurotoxicity The objective of this proposed project is to test the hypothesis that a new class of redox active metalloporphyrins is an effective radio protector and tumor sensitizer in brain tissue The specific aims are to perform a Phase clinical trial of this new drug in combination with standard RT and TMZ in newly diagnosed high grade glioma patients and perform a randomized open label Phase clinical trial of the new drug in combination with standard RT and TMZ versus standard RT and TMZ alone in patients with newly diagnosed high grade glioma patients The primary outcome is protection improvement of cognition This new class of drug has the potential to protect against deterioration of cognition and improve health related quality of life in high grade glioma patients undergoing RT and chemotherapy while also enhancing patient survival PUBLIC HEALTH RELEVANCE Phase and Phase clinical trials of a new class of redox active pharmaceutical are proposed in high grade glioma HGG This new class of drug has the potential to protect against deterioration of cognition and improve health related quality of life HRQoL in brain tumor patients undergoing RT and chemo therapy while also enhancing patient survival

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

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