RE: Back on board13 Jul 2021 08:33
Tue, 13th Jul 2021 07:00
RNS Number : 9890E
Evgen Pharma PLC
13 July 2021
Evgen Pharma plc
("Evgen" or the "Company")
Glioma Orphan Drug application submitted to US Food and Drug Administration
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases, announces the filing of an Orphan Drug Designation Request with the US Food and Drug Administration (''FDA'') for use of SFX-01 to treat malignant glioma.
Over the last year a strong package of preclinical data has been developed in in vitro and in vivo glioblastoma ("GBM") models. In particular, data generated 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. Recently the in vitro 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.
The Company, with its regulatory advisers has submitted an Orphan Drug application to the FDA. It is expected that, if granted, Orphan Drug ("OD") status would be conferred for SFX-01 in the US this year. OD is usually granted when there are fewer than 200,000 patients with a given disease in the United States and there is a scientific rationale for potential use of the product in that condition. In addition to recognising the relative rareness of a disease and the implications for clinical trials, a successful OD confers separate intellectual property cover to an investigational drug in the form of data protection which is additional to any patent cover in force. Ultimately tax credits are possible on eventual US sales of an approved orphan drug.
In parallel, an Investigational New Drug dossier is being prepared for submission to the FDA around the end of the year, to support a Phase II trial in glioma/glioblastoma that is being planned for commencement in H1/2022.
Dr Huw Jones, CEO of Evgen, commented: "Given the progress with our glioma programme and our intent to commence trials in 2022, we are seeking Orphan Drug status to maximise our intellectual property protection, commercial potential and partner appeal in this devastating disease. The incentives offered by OD designation mean that rare diseases like glioblastoma are more likely to be researched in the clinic. ''
Sign In
Follow the stocks
