FDA Clears IND Application For NT-I7, a PML Treatment

The FDA has recently accepted NeoImmuneTech’s Investigational New Drug (IND) application for NT-17, a treatment for progressive multifocal leukoencephalopathy (PML). Now that the application has been cleared, the biopharmaceutical company can move forward with a pilot study.

About PML

Progressive multifocal leukoencephalopathy is a rare neurological condition caused by John Cunningham virus (JCV), which infects people during their childhoods and remains inactive in the lymphoid organs and kidneys. Unless the immune system is severely weakened, the infection will not progress into PML. If it does transform into PML, affected individuals will see the destruction of myelin. This destruction then causes lesions throughout the central nervous system. Depending on where these lesions are, the symptoms vary. Possible symptoms include:

  • Vision loss
  • Mental impairments
  • Coordination and gait problems
  • Speech disturbances
  • Weakness
  • Loss of senses
  • Facial drooping
  • Seizures

Approval for NeoImmuneTech’s IND Application

Now that the FDA has approved of the IND application, NeoImmuneTech can move into their pilot study of NT-17. Dr. Irene Cortese will lead the study, stating that she wants to “restore the antiviral immune response.” As this drug is meant to provoke and quicken immune reconstitution, Dr. Cortese and other researchers are hopeful that it will be a viable treatment for PML.

Looking specifically to NT-17, it is intended to treat various immunologic and oncologic conditions. This long-acting human IL-7 is able to amplify T cells, as well as improve their functionality. It is currently being investigated for a number of indications, such as solid tumors and as a vaccine adjuvant.

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