Business
Progress with Glioma/Glioblastoma programme
Progress with Glioma/Glioblastoma programme.
About this update from Theracryf Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 7157B\n Evgen Pharma PLC\n 14 June 2021\n \n \n \n \n 14 June 2021\n \n \n Evgen Pharma plc\n \n \n \n \n \n (\"Evgen\" or the \"Company\")\n \n \n \n \n \n Progress with Glioma/Glioblastoma programme\n \n \n \n \n \n Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces further progress and an update on clinical trial plans for SFX-01 in glioblastoma (\"GBM\"). \n \n \n \n \n \n Glioma is the most common form of brain tumour affecting around 5 per 100,000 people. The more severe, grade IV classification, glioblastoma, is a very serious form of brain tumour representing 45% of all cases and has a poor prognosis with median survival of around 14 months. Together with neuroblastoma, GBMs now account for more deaths in the under 40s than any other tumour. \n \n \n \n \n \n Previously the Company reported that these data generated by Dr Claudio Festuccia at University L'Aquila showed that with in vivo pre-clinical subcutaneous and orthotopic models (where glioma cells are implanted in brain tissue representing a more disease-relevant model), SFX-01 produced tumour shrinkage and significantly extended survival times. SFX-01 was also found to potentiate (i.e. substantially increase) the therapeutic effect of radiotherapy in these models. \n \n \n \n \n \n Evgen now report that the in vitro these data from these experiments have been reproduced with very similar results at the University of Auckland using cells generated from freshly extracted patient GBM tissue, rather than the standard GBM cell lines established many decades previously. Further in vivo work has commenced at a contract research organisation to build upon the subcutaneous GBM tumour model experiments conducted by Dr Festuccia.\n \n \n \n \n \n Plans for a Phase II GBM clinical trial with an adaptive design are progressing with a scheduled start in the first half of 2022. In tandem work has started with regulatory advisers on preparation of an Investigational New Drug application for submission to the US Food and Drug Administration in Q4/2021.\n \n \n \n \n \n The therapeutic options for GBM are limited to surgery, radiotherapy and the one drug widely available, temozolomide. There is a clear unmet need for more treatments for use in conjunc...