Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, recently announced that its Toca 511 was awarded PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for treating high grade glioma (HGG) patients.
The designation comes on the heels of positive Phase 1 clinical data. In that study, Toca 511 showed promising results for safety and patient survival. Toca 511 is now in the midst of an international, randomized Phase 2/3 clinical trial.
HGG is a common form of brain cancer that is highly aggressive. More than 160,000 people across the world, including roughly 36,000 in Europe, are expected to be diagnosed with HGG in 2017.
"The EMA's granting of PRIME designation for Toca 511 underscores the urgent need for new treatments for high grade glioma, one of the deadliest cancers," Tocagen CEO Marty Duvall said in a statement. "We are committed to working closely with the EMA to expedite the advancement of our product candidate, and bringing a potentially transformative treatment option for high grade glioma to European patients and physicians as quickly as possible."
The PRIME program was launched by the EMA in 2016; its goal is to support medicines that target unmet health needs.