In the first half of 2020, the revolutionary global clinical trial for brain cancer patients, GBM AGILE, continues to make impressive progress and achieve milestones. AFCR supported its conception in 2013 to expeditiously develop new effective treatments for GBM brain cancer patients whose five-year survival rate is currently only 5% or less. In the new adaptive design of GBM AGILE trial, multiple treatment arms are investigated against a common control arm, allowing researchers to identify drugs that are showing promising results and seamlessly transition them to a confirmatory stage designed to support fast drug approval.
In June 2020, a third treatment arm in the trial was announced. The innovative DNA-targeting chemotherapeutic, VAL-083, from DelMar Pharmaceuticals, was selected and has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials.
To date, there are currently twenty-five trial sites enrolling patients in the U.S. with numerous sites opening in the rest of this year. Currently, 200 patients have been screened for evaluation of enrollment.
In Canada, six sites are planned: Montreal, Quebec; two in Toronto, Ontario; Edmonton, Alberta; Sherbrooke, Quebec; and Winnipeg, Manitoba. In discussions with the European Medicines Agency (EMA), 20-25 sites are being considered in: Austria; France; Germany; Italy; Netherlands; Spain; Switzerland; and the UK.
In China, the IND submission has been planned and GBM AGILE projects that the first site will be activated in Q1 2021. Currently, principle investigators at ten (10) major Chinese hospitals are in partnership discussions for GBM AGILE trial site:
- Tiantan Hospital, Beijing
- Huashan Hospital, Shanghai
- PUMC Cancer Hospital, Beijing
- Huaxi Hospital, Chengdu
- 301 PLA Hospital, Beijing
- Tianjin Cancer Hospital, Tianjin
- Sun Yat-Sen University Cancer Hospital, Guangzhou
- Second Affiliated Hospital, Zhejiang University, Hanzhou
- Shengjing Hospital of China Medical University, Shenyang
- Tangdu Hospital, Xi’An