Glioblastoma Multiforme Clinical Trial
Official title:
A Phase 2, Randomized, Open-Label Study of Anhydrous Enol-Oxaloacetate in Subjects With Newly Diagnosed Glioblastoma Multiforme
This is a multicenter, Phase 2, Proof-of-concept study in subjects with newly diagnosed
glioblastoma multiforme (GBM).
All subjects will receive standard of care therapy for the treatment of their GBM and any
Anti-Epileptic Drug (AED) deemed necessary for their surgical resection of the GBM. Patients
who are taking concomitant AEDs will be eligible for the study. Treatment with Anhydrous
Enol-Oxaloacetate will be added to the Standard of Care.
This study is testing adjuvant Anhydrous Enol-Oxaloacetate (AEO) in GBM, an orally active
drug candidate which in animal studies has demonstrated decreased tumor growth rate and
increased survival.
Currently, the multidisciplinary Standard of Care treatment for Glioblastoma multiforme
includes maximal surgical resection of the tumor followed by radiotherapy plus concomitant
and maintenance temozolomide chemotherapy.This study will treat newly diagnosed GBM patients
by adding Anhydrous Enol-Oxaloacetate treatment to their current Standard of Care.
In the body, Anhydrous Enol-Oxaloacetate (AEO) converts into "Oxaloacetate", a metabolite
important for many biochemical reactions in the body. On a cellular level, oxaloacetate
treatment has been found to modify cancer metabolism in GBM cells, reversing the "Warburg
Effect", reducing glycolysis and reducing lactate production. In animals, oxaloacetate
treatment has increased survival and reduced tumor growth of implanted GBM tumors.
In other animal studies, oxaloacetate has also shown to have neuo-protective effects
including positive effects on seizure development.
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