Shares of Evgen Pharma (LON: EVG) are trading higher on Tuesday after the company revealed it has submitted an Orphan Drug Designation Request with the US Food and Drug Administration (FDA) for the use of SFX-01 to treat malignant glioma.
The company said over the past year, it has collected and developed a “strong package of preclinical data in in vitro and in vivo glioblastoma (GBM) models”.
More specifically, data generated at the University L’Aquila in Italy showed that with in vivo preclinical subcutaneous and orthotopic models, SFX-01 produced tumour shrinkage and significantly extended survival times.
SFX-01 was also said to substantially increase the therapeutic effect of radiotherapy in these models.
If the application is accepted, Evgen believes Orphan Drug status would be granted this year.
Orphan Drug status is usually granted when there are fewer than 200,000 patients with a given disease in the United States and will give the company separate intellectual property cover to an investigational drug in the form of data protection and tax credits on possible eventual US sales of the drug.
Additionally, Evgen is preparing an Investigational New Drug dossier for submission to the FDA around the end of the year, supporting a Phase 2 trial in glioma/glioblastoma planned for the first half of 2022.
“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,” said Dr Huw Jones, CEO of Evgen.
“The incentives offered by OD designation mean that rare diseases like glioblastoma are more likely to be researched in the clinic.”
Evgen Pharma’s share price is currently up 9% to 5.14p following the news. It initially hit a high of 5.4p at the open.
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