Hemerion Planning Phase 2 Trial at Mt. Sinai NY in 2022In 2022, in collaboration with Hemerion Therapeutics, Drs. Yong and Hadjipanayis of Mount Sinai Hospital, New York will begin a phase 2 clinical trial of intraoperative photodynamic therapy for GBM patients after tumour resection using the photosensitizer 5-ALA, which is already approved by the FDA for fluorescence-guided surgery in glioma patients.
Hemerion is hoping the treatment will become the standard of care by late 2026.
On 12 January 2017, orphan designation was granted by the European Commission to Centre Hospitalier Universitaire de Lille, France, for 5-aminolevulinic acid for the treatment of glioma.
The sponsorship was transferred to Hemerion Therapeutics, France, in December 2020.
Orphan designation has many advantages and one of them is ten years of market exclusivity.
In Europe at least, authorised orphan medicines benefit from ten years of protection from market competition with similar medicines with similar indications once they are approved.