Hemispherian AS, a Norway-based biotech company developing next-generation therapeutics for aggressive cancers, announced on Friday that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Orphan Drug Designation (ODD) for GLIX1, its lead molecule, for the treatment of glioma, a potentially lethal brain cancer.

This designation recognises both the urgent unmet medical need in glioma and the potential of GLIX1 to provide significant clinical benefit beyond current therapies.

Glioma is a life-threatening and chronically debilitating disease affecting approximately 2.6 in 10,000 people in the EU. Existing therapies for glioblastoma (a form of glioma) offer only limited survival benefits, with median overall survival typically less than 15 months.

Non-clinical studies with GLIX1 have demonstrated significant tumour reduction and extended survival in validated animal models, including cases of complete tumour eradication. These results suggest that GLIX1 offers a clinically relevant advantage over existing treatments, fulfilling the EMA's criteria for 'significant benefit'.