Cellevolve Bio Receives Both IND Clearance and Orphan Drug Nod for Brain Infection Drug

The FDA has cleared Cellevolve Bio’s Investigational New Drug (IND) application for CE-VST01-JC and granted it Orphan Drug designation for treating progressive multifocal leukoencephalopathy (PML), a rare brain infection.

PML is caused by a virus infection that targets cells that make myelin, the material that insulates neurons. The life expectancy for patients diagnosed with advanced PML is typically between six months and one year.

The company plans to begin a phase 2 study to evaluate whether CE-VST01-JC will slow and ultimately halt neurological progression among those suffering from PML.

There are currently no FDA-approved treatments for the condition.