A local biotech company just got a big distinction by the Food and Drug Administration (FDA) that could help speed up the approval of a brain cancer drug.
On Thursday, Tocagen, a clinical-stage cancer-selective gene therapy company based in Mission Beach, was granted a breakthrough therapy designation for the treatment of patients with recurrent high grade glioma.
"The real importance here is the continuous dialogue," Tocagen chief executive officer Marty Duvall told NBC 7. "The FDA has determined, based on its review of our product, that this has potential significant advantage over existing therapy."
High grade gliomas are among the most common and aggressive primary brain cancers. Approximately 160,000 patients worldwide are expected to be diagnosed with HGG a year. Median survival after recurrence is typically seven to nine months, according to Tocagen.
“What we’ve seen with the early trials with our regime is that patients who are responding are actually living multiple years,” Duvall said.
The way the therapy works is twofold: once the tumor is removed, a doctor injects a virus in the infected area. That virus spreads through the remaining tumor cells. Then patients take an oral medication, which converts the virus into a powerful anti-cancer drug.
“There’s an initial killing of the tumor, then there’s a second punch where the immune system is activated and turns on against the cancer and then the patients can get very long term remissions,” Tocagen President Harry Gruber said.
This twofold mechanism is what Tocagen believes is creating these promising, long-term results.