Randomized Prospective Phase II Clinical Trial of NVX in Association with Chemoradiation of Glioblastoma

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA144817-03
Agency Tracking Number: R44CA144817
Amount: $1,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: CA16-008
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-12
Award End Date (Contract End Date): 2021-02-28
Small Business Information
1635 E. 18TH ST, Tucson, AZ, 85719-6803
DUNS: 825136141
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 EVAN UNGER
 (601) 626-4888
 eunger@radioloogy.arizona.edu
Business Contact
 BETTY WEAVER
Phone: (520) 624-6688
Email: bweaver@nuvoxpharma.com
Research Institution
 Stub
Abstract
Glioblastoma multiforme GBM is a malignant primary brain tumor affecting about new cases per year in the U S Average survival is only about months Radiation RT is most commonly administered as fractions of Gray each over weeks with concomitant temozolomide TMZ GBM tumors are hypoxic The primary mechanism of RT is creation of singlet oxygen hypoxia within GBM adversely affects response to RT and decreases survival NVX dodecafluoropentane emulsion DDFPe transports over x as much O per gram of fluorocarbon FC than higher MW FC e g Fluosol and perfluorooctylbromide previously studied as O therapeutics which failed NVX clears via exhalation with a terminal half life in humans of about minutes In tumor xenografts NVX significantly increases tumor pO with a duration of effect andgt two hours following IV administration Animal tumor models show improved survival with NVX RT versus RT alone NVX is presently being tested as a radiosensitizer in patients with GBM administered prior to each fraction of RT with concomitant TMZ In this trial we are obtaining gene profiling on tumor specimens and TOLD MRI to evaluate tumor O pre and post NVX The drug is safe there is evidence of tumor re oxygenation on TOLD MRI and therapeutic efficacy The first patient TMZ non responder survived months The second patient is alive at months TMZ responder but was years of age at diagnosis a patients years of age and older only have predicted survival of about months All other patients are currently alive treated to date DDFPe was previously tested as an ultrasound contrast agent in patients NuvOx licensed the patents and obtained ownership of the regulatory documents for DDFPe The FDA has agreed that NuvOx can reference these documents in support of development of NVX The FDA will regulate NVX as a Biologic Regulation as a Biologic confers years of exclusivity for a first in class indication NuvOx has received Orphan Drug Designation for NVX for glioblastoma Specific Aim To file an IND for a randomized prospective placebo controlled trial of NVX to treat GBM Specific Aim Conduct randomized placebo controlled trial of NVX in chemoradiation of GBM Experimental design Patients will be randomized to placebo O breathing or IV infusion of NVX O breathing prior to each fraction of RT Gy per fraction fractions over weeks with concomitant TMZ The initiation of the Phase II trial will occur at the University of Arizona Barrow Neurological Institute BNI the Miami Cancer Institute and Banner MD Anderson In addition patients will undergo TOLD MRI to assess tumor O Otherwise patients will have standard of care therapy and standard follow up Depending upon accrual and other factors we plan to initiate additional sites Expected outcome Successful completion of the Aims proposed in this study should confirm that NVX re oxygenates GBM and show improved survival in association with treatment with chemoradiation Glioblastoma primary brain cancer is a deadly disease with only about months of survival after treatment usually consisting of surgery followed by radiation and chemotherapy Glioblastoma is a hypoxic low oxygen in tissue tumor and this lack of oxygen limits response to therapy because radiation primarily acts by creating oxygen free radicals We have developed a safe nanotechnology product that following IV administration raises oxygen levels in tumor tissue to improve response to radiation and improve survival and outcomes in these patients

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

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