Orphan Designation Granted by EMA to MTX110 Development for the Treatment of Glioma
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on improving the bio-delivery and biodistribution of medicines, is pleased to announce that following the submission of an application to the European Medicines Agency (“EMA”), its development programme of MTX110 for the treatment of glioma has been granted Orphan Medicinal Product designation by the agency.
Midatech has been developing MTX110 for the treatment of recurrent glioblastoma (“rGBM”) in adult patients and diffuse intrinsic pontine glioma (“DIPG”) and medulloblastoma in paediatric patients.
Orphan designation is granted by the EMA to medicines that meet pre-specified criteria, including treatment of a life-threatening condition and prevalence of no more than 5 in 10,000 in the EU. The designation is intended to offer a range of incentives that facilitate development of the medicine, such as protocol development assistance, reduction in fees and market exclusivity upon successful approval of the drug.
Commenting, Dmitry Zamoryakhin, CSO of Midatech, said: “Both rGBM and DIPG are devastating and incurable cancers marked by short survival rates and universal recurrence. Receiving Orphan designation for MTX110 is an important milestone for the development of the drug, as it demonstrates the need for novel and effective treatment options for these fatal diseases and highlights a potential benefit that the development of MTX110 might bring to patients.”