Midatech Pharma PLC, an R&D biotechnology company, announced that upon submitting an application to the US Food and Drug Administration (FDA), its development programme of MTX110 for the treatment of recurrent glioblastoma (rGBM) has been granted Fast Track designation by the agency.
Fast Track is a process designed to facilitate the development and expedite the review of treatments for serious conditions and that potentially address unmet medical needs. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.
Commenting, Dmitry Zamoryakhin, CSO of Midatech, said: "rGBM is a devastating cancer marked by short survival rate and universal recurrence. Receiving Fast Track 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 this currently universally fatal disease. MTX110, our water-soluble formulation of Panobinostat, will soon start recruitment into a company-sponsored phase I study in patients with recurrent GBM."
MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-
