13th Jul 2021 14:09
Evgen Pharma PLC - Manchester-based clinical stage drug development company - Reports filing of an orphan drug designation request with the US Food & Drug Administration for use of SFX-01 to treat malignant glioma. In parallel, an investigational new drug dossier is being prepared for submission to the US regulator around the end of the year, to support a phase II trial in gliomas that is being planned to begin in 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," says Huw Jones, Evgen chief executive.
"The incentives offered by Orphan Drug designation mean that rare diseases like glioblastoma are more likely to be researched in the clinic."
In other company news Evgen reports early preclinical data shows SFX-01 was "effective" in in vitro models of some blood cancers.
"The study investigated the effect of SFX-01 on cells from tissue donated by patients with juvenile myelomonocytic leukaemia, through the UK Paediatric MDS/JMML study," company says, adding: "The study also showed that SFX-01 significantly impacted cell proliferation and increased cytotoxicity in GDM-1 cells, an acute myelomonocytic leukaemia cell line."
Current stock price: 5.27 pence, up 13% Tuesday afternoon
Year-to-date change: down 48%
By Will Paige; [email protected]
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