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  • ||||||||||  dianhydrogalactitol (VAL-083) / Kintara Therap
    VAL-083 in patients with recurrent glioblastoma treated under expanded access program (Section 34; Poster Board #10) -  Mar 14, 2023 - Abstract #AACR2023AACR_4426;    
    P=N/A
    Current standard-of-care for glioblastoma (GBM) includes surgery followed by concurrent therapy with radiation and temozolomide (TMZ) and adjuvant TMZ...Seven patients received bevacizumab concurrently with VAL-083...Five patients with thrombocytopenia had prior lomustine...Additional safety and efficacy measures will be presented at the meeting.Clincialtrials.gov Identifier: NCT03138629. All EA treatment requests and plans were approved by MD Anderson Cancer Center IRB.
  • ||||||||||  dianhydrogalactitol (VAL-083) / Kintara Therap
    VAL-083 in Patients with Recurrent Glioblastoma Treated under Expanded Access Program (West/Central Hall) -  Sep 28, 2022 - Abstract #SNO2022SNO_522;    
    P=N/A
    All patients had received chemoradiation with temozolomide...Five patients with cerebral edema refractory to steroids received bevacizumab (BEV; 10 mg/kg) concurrently with VAL-083, and 8 patients received dexamethasone (Dex; >4 mg/day) with VAL-083...Additional treatment, safety and outcome data will be presented at the meeting.Clinicaltrials.gov Identifier: NCT03138629. EA treatment plans were approved by MD Anderson Cancer Center IRB.
  • ||||||||||  Trial completion date, Trial primary completion date:  GBM AGILE: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (clinicaltrials.gov) -  Jun 30, 2022   
    P2/3,  N=1030, Recruiting, 
    Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Oct 2022 Trial completion date: Jun 2024 --> Jun 2028 | Trial primary completion date: Dec 2023 --> Jun 2026
  • ||||||||||  dianhydrogalactitol (VAL-083) / Kintara Therap
    Trial completion date, Trial primary completion date, Epigenetic controller:  Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression (clinicaltrials.gov) -  Mar 24, 2022   
    P2,  N=30, Active, not recruiting, 
    Trial completion date: Jun 2024 --> Jun 2028 | Trial primary completion date: Dec 2023 --> Jun 2026 Trial completion date: Aug 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Nov 2021
  • ||||||||||  dianhydrogalactitol (VAL-083) / Kintara Therap
    Dianhydrogalactitol (VAL-083) for the treatment of glioblastoma multiforme (GBM): Impact of glucose transporters for crossing the blood brain barrier (BBB) (Section 24) -  Mar 9, 2022 - Abstract #AACR2022AACR_4053;    
    These include the nitrosoureas such as carmustine (BCNU) and lomustine (CCNU) and temozolomide (TMZ)...The probe substrate methyl-α-D- glucopyranoside (AMG) was used as a positive control, as well as comparison against the reference inhibitors phloridzin dihydrate (100 µM, 20 min) for SGLT1 and dapagliflozin (0.3 µM, 10 min) for SGLT2...GLUT1 is expressed on erythrocytes and the endothelial cells of the BBB and may be highly relevant to the uptake of VAL-083 into brain tissue. The results of these studies will be reported at the meeting.
  • ||||||||||  Review, Journal:  Neurocytological Advances in the Treatment of Glioblastoma Multiforme. (Pubmed Central) -  Aug 19, 2021   
    Most trials observe modest improvement in outcomes with a positive safety profile. Nevertheless, the need for further studies is warranted, along with the trending of post-therapeutic biomarkers in order to better access future patient outcomes.
  • ||||||||||  dianhydrogalactitol (VAL-083) / Valent Tech
    Enrollment closed, Trial completion date, Trial primary completion date:  Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting (clinicaltrials.gov) -  Jun 8, 2021   
    P2,  N=119, Active, not recruiting, 
    Nevertheless, the need for further studies is warranted, along with the trending of post-therapeutic biomarkers in order to better access future patient outcomes. Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Sep 2021
  • ||||||||||  dianhydrogalactitol (VAL-083) / Kintara Therap
    Trial completion date, Trial primary completion date, Epigenetic controller:  Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression (clinicaltrials.gov) -  Jun 8, 2021   
    P2,  N=30, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Sep 2021 Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2020 --> Jun 2021
  • ||||||||||  dianhydrogalactitol (VAL-083) / Kintara Therap
    Journal, BRCA Biomarker:  Dianhydrogalactitol synergizes with topoisomerase poisons to overcome DNA repair activity in tumor cells. (Pubmed Central) -  Mar 27, 2021   
    Importantly, DAG combined with irinotecan treatment enhanced tumor responses and prolonged survival of tumor-bearing mice. This work provides mechanistic insight into DAG cytotoxicity in GBM and PCa cells and offers a rational for exploring combination regimens with topoisomerase I/II poisons in future clinical trials.